Connector with integrated non-return check valve for extension tubing and urology collection systems

ABSTRACT

A connector-with-integrated-check-valve for minimizing microbial migration to catheter-tubing is formed from three parts: a connector-for-catheter-tubing that is hollow and with an internal valve seat; an elastomer disc shaped gate; and a connector-for-extension-tubing that is hollow and with support-surfaces. When one end of the connector-for-catheter-tubing is attached to one end of the connector-for-extension-tubing, a pocket is formed where the seat is disposed opposite and facing the support-surfaces; the gate is disposed within this pocket; such that when the gate contacts this seat due to urine backflow (reflux), the connector-with-integrated-check-valve is closed to such urine backflow; and where a remaining end of the connector-for-catheter-tubing is attachable to catheter-tubing; and where a remaining end of the connector-for-extension-tubing is attachable to the extension-tubing, such that there is a continuous urine flow path from the catheter-tubing, to the connector-with-integrated-check-valve when open, and to the extension-tubing.

PRIORITY NOTICE

The present patent application is a continuation-in-part (CIP) of U.S.non-provisional patent application Ser. No. 14/281,524 filed on May 19,2014 and claims priority to said U.S. non-provisional patent applicationunder 35 U.S.C. §120. The above-identified patent application isincorporated herein by reference in its entirety as if fully set forthbelow.

The present application also claims priority under 35 U.S.C. §119(e) toU.S. Provisional Patent Application Ser. No. 62/389,288 filed on Feb.22, 2016, the disclosure of which is incorporated herein by reference inits entirety as if fully set forth below.

STATEMENT REGARDING FEDERAL SPONSORSHIP

No part of this invention was a result of any federally sponsoredresearch.

TECHNICAL FIELD OF THE INVENTION

The present invention relates in general to urinary tubing and morespecifically to flexible urinary tubing, such as extension tubing, whichmay comprise various means for minimizing microbial migration in adirection opposite of intended flow. Additionally, a system and a methodfor forming an anti-reflux extension tubing system with respect tourinary tubing connected to a catheter and urine container are describedand disclosed.

COPYRIGHT AND TRADEMARK NOTICE

A portion of the disclosure of this patent application may containmaterial that is subject to copyright protection. The owner has noobjection to the facsimile reproduction by anyone of the patent documentor the patent disclosure, as it appears in the Patent and TrademarkOffice patent file or records, but otherwise reserves all copyrightswhatsoever.

Certain marks referenced herein may be common law or registeredtrademarks of third parties affiliated or unaffiliated with theapplicant or the assignee. Use of these marks is by way of example andshould not be construed as descriptive or to limit the scope of thisinvention to material associated only with such marks.

BACKGROUND OF THE INVENTION

One in five patients admitted to hospitals receive an indwelling urinarycatheter (hereinafter, “catheter”). When a patient receives a catheter,and the longer the catheter is placed inside the body, the more likelythe patient will develop a urinary tract infection (UTI).Hospital-associated infections (HAIs) are infections acquired during thecourse of receiving treatment for other conditions within a hospitalsetting. In the United States according to the Centers for DiseaseControl and Prevention (CDC) more than four million patients developHAIs in the United States each year with about 99,000 of such casesresulting in death.

UTIs may be caused by microbes (e.g. bacteria) entering the body throughthe catheter. The distribution of microbes among patients withhospital-acquired urinary tract-related bloodstream infections mayinclude: enterococcus, candida, E. coli, klebsiella, staphylococcus, andthe like. According to the ICHP, the urinary tract is the most commonsite of HAIs and accounts for more than 64% of catherized patients inacute-care hospitals. In 2014, the CDC released a HAI Progress Reportstating that among five categories of HAIs, only catheter-associatedurinary tract infections (CAUTI) had an increase of incidents. Due tothe increase of CAUTIs, the Centers for Medicare and Medicaid Services(CMS) will not allow hospitals to be reimbursed for treating ahospital-acquired CAUTI because nosocomial CAUTIs and are believed to be“reasonably preventable.” The cost of treating UTIs could cost U.S.hospitals between $1.6 billion and $7.39 billion annually in lostMedicare reimbursements since treating each CAUTI incident may costbetween US$600 to US$2,800 to treat.

Microbes may travel intraluminally in the urinary system at least twoways: (1) suspended and floating microbial cells within the urine (i.e.,bacteriuria) where there is backflow (reflux) of infected urine; and (2)by biofilm migration (i.e., colonies of microbial cells that may formlayers and attach themselves to surfaces) that may ascend up through theinside of urinary tubing surfaces and into the catheter and potentiallyenter the patient's body. Research currently suggests that preventingurine backflow (reflux) from entering the catheter and/or incorporatinga hurdle or barrier that prevents biofilms from ascending through theurinary collection system would help to mitigate the number of UTIs.Currently, the number of patients developing bacteriuria or UTIs aftertwo and three days is 10% to 30%; while after one week or longer is near90%, and; long-term catheterization (of one month or more) results innear 100% of patients with bacteriuria or UTIs. Although not all CAUTIsmay be prevented, it is believed by the medical community that asubstantial number of CAUTIs may be avoided by the proper management ofindwelling and external catheters. CMS developed a list ofrecommendations and guidelines to help reduce UTIs and CAUTIs. One ofthese recommendations included preventing backflow (reflux) of urinewhich could contain bacteriuria or other microbes. Furthermore,prevention may be the best way to manage nosocomial UTI, as opposed tofocusing on expensive treatment and medicine, which may or may not beeffective, as many microbes are becoming increasingly less sensitive andmore resistant to antibiotics.

A first and second anti-reflux barrier (e.g., one or more check-valvesand/or one or more clamps) within a urinary system (e.g., comprisingextension tubing and one or more check-valves) may be beneficial bydenying microbes various routes of entry into the patient. If such asystem is breached (e.g., by inappropriate opening), then microbes mayenter the extension tubing and catheter and travel up into the urethraor body wall of the patient and infect the patient.

To date (circa 2014), the inventor is not aware of any prior art thatspecifically addresses a device or component that forms an anti-refluxextension tubing system or where such a device or component may preventurine backflow (reflux) of urine located within urinary extension tubingthat connects the urinary indwelling and/or external catheter to theurine bag, or where such a device or component may prevent biofilmmigration. Reference should also be made that there are no commercialproducts currently available that specifically addresses prevention ofurine backflow in urinary collection systems, such as the extensiontubing, by placing a check-valve inside the urinary extension tubing orwithin a connector of the extension tubing.

Rather, unrelated prior art consists of inventions for closed-system andanti-reflux system are irrigation connectors, intravenous syringe ports,closed adapters for enteral formula delivery, and needleless IV accessports for small bore luers—i.e., none of this prior art deals withurinary systems.

For example, some such prior art include: preventing backflow for bloodand urine specimens (i.e., not urinary collection system) andmaintaining a closed-system for irrigation; and of using check-valves infeeding tubes. Such prior art does not incorporate any anti-refluxcheck-valve within the primary urinary extension tubing running from theindwelling catheter to the urine bag.

Additionally, the prior art may include a check-valve located within aurine bag. This prior art may prevent urine backflow (reflux) from theurine bag into the extension tubing. However, the urine collectionsystem between the urine bag and the patient is vulnerable and presentlyhas no barrier against urine backflow. If there is no anti-reflux valve(i.e., check-valve) present before the catheter to prevent urinebackflow, then microbes in the urine may travel from the urine in tubinginto the catheter leading to a CAUTI.

There is a need in the art for satisfactorily addressing and reducingthe high percentage of UTIs and CAUTIs that occur with currentindwelling and/or external urinary catheter use.

It is to these ends that the present invention has been developed.

BRIEF SUMMARY OF THE INVENTION

To minimize the limitations in the prior art, and to minimize otherlimitations that will be apparent upon reading and understanding thepresent specification, the present invention may describe aconnector-with-integrated-check-valve for minimizing microbial migrationto catheter-tubing as well as a system for minimizing microbialmigration to the catheter-tubing.

In some embodiments, the connector-with-integrated-check-valve forminimizing microbial migration to catheter-tubing may be formed fromthree parts: a connector-for-catheter-tubing that is hollow and with aninternal valve seat; an elastomer disc shaped gate; and aconnector-for-extension-tubing that is hollow and with support-surfaces.When one end of the connector-for-catheter-tubing is attached to one endof the connector-for-extension-tubing, a pocket is formed where the seatis disposed opposite and facing the support-surfaces; the gate isdisposed within this pocket; such that when the gate contacts this seatdue to urine backflow (reflux), theconnector-with-integrated-check-valve is closed to such urine backflow;and where a remaining end of the connector-for-catheter-tubing isattachable to catheter-tubing; and where a remaining end of theconnector-for-extension-tubing is attachable to the extension-tubing,such that there is a continuous urine flow path from thecatheter-tubing, to the connector-with-integrated-check-valve when open,and to the extension-tubing.

It is an objective of the present invention to provide urinary extensiontubing and/or a connector-with-integrated-check-valve that may becapable of minimizing microbial migration in a direction opposite ofintended flow, by utilizing the various means discussed herein,specifically in the DETAILED DESCRIPTION OF THE INVENTION section ofthis specification.

It is another objective of the present invention to provide urinaryextension tubing that may be capable of minimizing urine backflow(reflux) from the intended flow of urine within the urinary extensiontubing and preventing backflow into a catheter.

It is another objective of the present invention to provide urinaryextension tubing that may comprise at least one check-valve positionedwithin the urinary tubing or within a connector attached to theextension tubing, i.e., a connector-with-integrated-check-valve.

It is another objective of the present invention to provide urinaryextension tubing that may comprise at least one biofilm abaterpositioned within the urinary tubing to minimize biofilm migrationacross the at least one biofilm abater. See the DETAILED DESCRIPTION OFTHE INVENTION section for a discussion of biofilm abaters.

It is another objective of the present invention to provide urinaryextension tubing and/or a connector-with-integrated-check-valve, thatmay comprise at least one wettable region (e.g., a region of urinarytubing inside diameter) treated with an antimicrobial coating lining atleast some portions the luminal walls (interior walls) of the urinarytubing to minimize biofilm migration across the at least one wettableregion treated with the antimicrobial coating.

It is another objective of the present invention to provide urinaryextension tubing that may comprise various connectors, both with andwithout check-valves, where such connectors may be positioned within theurinary tubing, at the first terminal end, and/or the second terminalend, wherein such connectors (and/or tubing) may be treated (e.g., bycoating) with an antimicrobial coating to mitigate against biofilmmigration across such connectors treated with the antimicrobial coating.

It is another objective of the present invention to provide a method orseries of methods for forming and maintaining an anti-reflux extensiontubing system with respect to urinary extension tubing connected to acatheter.

It is yet another objective of the present invention to provide systemsfor forming and maintaining an anti-reflux extension tubing system withrespect to urinary tubing connected to a catheter.

These and other advantages and features of the present invention aredescribed herein with specificity so as to make the present inventionunderstandable to one of ordinary skill in the art, both with respect tohow to practice the present invention and how to make the presentinvention.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

Elements in the figures have not necessarily been drawn to scale inorder to enhance their clarity and improve understanding of thesevarious elements and embodiments of the invention. Elements that areknown to be common and well understood to those in the industry are notdepicted in order to provide a clear view of the various embodiments ofthe invention.

FIG. 1A depicts an embodiment of urinary tubing (hereinafter, “tubing”)connected at one end to a catheter and at the other end to a urine legbag, shown from a frontal view. The catheter is shown as connected to apatient.

FIG. 1B depicts an embodiment of tubing connected at one end to acatheter and at the other end to a urine bed bag, shown from alongitudinal side view. Here the catheter is connected to a patient thatis lying down on a bed.

FIG. 1C depicts an embodiment of tubing connected at one end to acatheter and at the other end to a urine bag, shown from a top view.

FIG. 2 depicts an embodiment of tubing comprising a connector integratedwith check-valve, where one end of the tubing is connected to an exitport of a catheter via the connector integrated with check-valve, shownfrom a top view.

FIG. 2A depicts the embodiment of the tubing of FIG. 2, shown from aclose up longitudinal cross-sectional view.

FIG. 2B depicts an embodiment of the tubing of FIG. 2A, but with anaddition of tape wrapping a connection between the catheter and thetubing, shown from a longitudinal cross-sectional view.

FIG. 3A depicts an embodiment of tubing which may comprise a connectorwith a non-integral check-valve, where one end of the tubing isconnected to an exit port of a catheter via the connector with the non-integral check-valve, shown from a longitudinal cross-sectional view.

FIG. 3B depicts an embodiment of the tubing of FIG. 3A, but with anaddition of tape wrapping a connection between the catheter and thetubing, shown from a longitudinal cross-sectional view.

FIG. 4 depicts an embodiment of tubing, but where the tubing may besub-divided at a joint into two smaller tubes such that a connectorintegrated with check-valve may be inserted between the two smallertubes to join the two smaller tubes, which then form the tubing, shownfrom a top view.

FIG. 4A depicts the embodiment of tubing of FIG. 4, shown from alongitudinal cross-sectional view.

FIG. 4B depicts an embodiment of the urinary tubing of FIG. 4A, butwhere the joint is circumscribed by a coupling sleeve, shown from alongitudinal cross-sectional view.

FIG. 5A depicts an embodiment of tubing, but where the tubing may besub-divided at a joint into two smaller tubes such that a connector withnon-integral check-valve may be inserted between the two smaller tubesto join the two smaller tubes, which then form the tubing, shown from alongitudinal cross-sectional view.

FIG. 5B depicts an embodiment of the urinary tubing of FIG. 5A, butwhere the joint is circumscribed by a coupling sleeve, shown from alongitudinal cross-sectional view.

FIG. 6A depicts an embodiment of tubing where a check-valve may havebeen inserted into the tubing by pushing the check-valve into a desiredlocation, shown from a longitudinal cross-sectional view.

FIG. 6B depicts an embodiment of tubing with a biofilm abater insertedinto the tubing, shown from a longitudinal cross-sectional view.

FIG. 6C depicts an embodiment of tubing with a biofilm abater insertedinto the tubing, shown from a top cross-sectional view.

FIG. 6D depicts an embodiment of tubing with a check-valve and with abiofilm abater inserted into the tubing (upstream of) the check-valve,shown from a longitudinal cross-sectional view.

FIG. 6E depicts an embodiment of tubing where an inner region of thetubing has an antimicrobial coating, and where the coated inner regionis upstream of a check-valve, shown from a longitudinal cross-sectionalview.

FIG. 6F depicts an embodiment of tubing where there are two check-valvesinserted into the tubing, in serial fashion, shown from a longitudinalcross-sectional view.

FIG. 6G depicts an embodiment of tubing which may comprise a samplingport, shown from a longitudinal cross-sectional view.

FIG. 6H depicts an embodiment of tubing which may comprise a graphicalindicator which may indicate which end of the tubing may be detachedfrom a urine bag, shown from a longitudinal cross-sectional view.

Note, with respect to the above stated cross-sectional views,cross-sections of the various connectors with integral check-valves,connectors with non-integral check-valves, and check-valves withoutconnectors are not depicted. Cross-section of the various cathetersampling ports are also not depicted.

Note, any breaks depicted in tubing length in the various figures mayindicate that the tubing may have a variety of lengths.

FIG. 7A may depict a perspective and longitudinal cross-sectional viewof an embodiment of a connector-with-integrated-check-valve that isattached to catheter-tubing at one end and attached to extension-tubingat the other end.

FIG. 7B may depict the same embodiment of FIG. 7A, but shown in anexploded, perspective, and longitudinal cross-sectional view.

FIG. 7C may depict the same embodiment of FIG. 7A, but shown in anexploded and a perspective view.

FIG. 7D may depict the same embodiment of FIG. 7A, but shown in alongitudinal cross-sectional view.

FIG. 7E may be a close up view of theconnector-with-integrated-check-valve shown in FIG. 7D, wherein theconnector-with-integrated-check-valve may be shown in an openconfiguration.

FIG. 7F may depict the same embodiment of FIG. 7A, but shown in alongitudinal cross-sectional view.

FIG. 7G may be a close up view of theconnector-with-integrated-check-valve shown in FIG. 7F, wherein theconnector-with-integrated-check-valve may be shown in a closedconfiguration.

FIG. 7H may depict the same embodiment of FIG. 7A, but shown in aperspective view.

FIG. 7I may show an outlet perspective view of an embodiment of aconnector-for-catheter-tubing, which may be a component of theconnector-with-integrated-check-valve shown in FIG. 7A.

FIG. 7J may show an inlet view of an embodiment of aconnector-for-extension-tubing, which may be a component of theconnector-with-integrated-check-valve shown in FIG. 7A.

FIG. 7K may depict an inlet perspective view of theconnector-for-extension-tubing shown in FIG. 7J.

FIG. 8 may depict a perspective and longitudinal cross-sectional view ofan embodiment of a connector-with-integrated-check-valve.

FIG. 9A may depict a perspective and longitudinal cross-sectional viewof an embodiment of a connector-with-integrated-check-valve.

FIG. 9B may depict the same embodiment of FIG. 9A, but shown in anexploded and a perspective view.

REFERENCE NUMERAL SCHEDULE

-   100 tubing 100-   101 first terminal end 101-   102 second terminal end 102-   103 inside diameter of tubing 103-   104 outside diameter of tubing 104-   200 tubing embodiment 200-   201 tubing embodiment 201-   205 connector with check-valve 205-   206 coupling sleeve 206-   206 b tape 206 b-   300 tubing embodiment 300-   301 tubing embodiment with tape 301-   307 connector 307-   308 check-valve 308-   400 tubing embodiment 400-   401 tubing embodiment 401-   409 first tube 409-   410 second tube 410-   411 third terminal end 411-   412 fourth terminal end 412-   500 tubing embodiment 500-   501 tubing embodiment 501-   601 check-valve pushed into place embodiment 601-   602 tubing embodiment 602-   603 tubing embodiment 603-   605 check-valve 605-   613 biofilm abater 613-   613 a outside diameter 613 a-   621 tubing embodiment 621-   622 inside surface region 622-   631 tubing embodiment 631-   632 sampling port 632-   633 linear distance 633-   641 tubing embodiment 641-   642 graphical indicator 642-   651 tubing embodiment 651-   700 connector-with-integrated-check-valve 700-   710 connector-for-catheter-tubing 710-   712 first-barb-region 712-   714 first-hollow-core 714-   716 mating-end 716-   718 seat 718-   720 central-flange 720-   730 connector-for-extension-tubing 730-   732 second-barb-region 732-   734 second-hollow-core 734-   736 complimentary-mating-end 736-   738 flange 738-   740 catch-arms 740-   742 support-surface 742-   744 receiving-distance 744-   746 posts 746-   750 gate 750-   752 pocket 752-   754 gate-outside-diameter 754-   770 desired-direction 770-   800 connector-with-integrated-check-valve 800-   830 connector-for-extension-tubing 830-   832 second-barb-region 832-   834 second-hollow-core 834-   836 complimentary-mating-end 836-   838 flange 838-   840 spring-stops 840-   845 closing-spring 845-   852 pocket 852-   900 connector-with-integrated-check-valve 900-   930 connector-for-extension-tubing 930-   932 second-barb-region 932-   934 second-hollow-core 934-   936 complimentary-mating-end 936-   938 flange 938-   940 pocket 940-   942 stop 942-   944 hinge-receiver 944-   950 gate 950-   954 gate-outside-diameter 954-   956 hinge 956-   9915 catheter 9915-   9917 catheter exit port 9917-   9901 urine bag 9901-   9901 a leg urine bag 9901 a-   9901 b bed urine bag 9901 b-   9902 urine bag connector 9902-   9910 patient 9910-   9920 catheter-tubing 9920-   9930 extension-tubing 9930

DETAILED DESCRIPTION OF THE INVENTION

Various embodiments of urinary tubing configured to minimize microbialmigration in a direction opposite of intended flow are described anddisclosed. A system and a method for forming and maintaining aclosed-system with respect to urinary tubing connected to a catheter arealso described and disclosed.

Before turning to a discussion of the invention's various structures,disclosures regarding various definitions and functional objectives ofthe inventive structures are disclosed. “Intended flow,” “microbe,“microbial,” “antimicrobial,” “system,” “closed-system,” and “tubing”are all defined below and in turn.

An example of “intended flow” may be a flow of urine beginning from apatient's urethra (or bladder or kidney) and flowing into and through aurinary catheter (through an inside diameter), then into urinary tubing(through an inside diameter), and finally into a urine bag (e.g., leg orbed). Such intended flow is generally accomplished by the catheter beingplaced within the patient's urethra (or bladder or kidney), followed bythe urinary tubing connected to an exit port of the catheter, and thenwith the urine bag connected at a remaining terminal end of the urinarytubing, and where the intended flow may be accomplished by eachsubsequent component being placed below the immediately prior component,i.e., to facilitate flow downhill. Intended flow of urine may be in asame direction of flow as desired-direction 770. Any urine flow oppositeof this intended flow direction is known as “backflow” or “reflux.” Anda primary objective of this invention is to mitigate against microbesmigrating in the direction opposite of the intended flow. For example,one way to minimize undesirable microbe migration, may be to prevent ormitigate against fluid (e.g., urine) backflow (reflux), since such fluidmay be carrying microbes.

However, regardless of fluid flow, microbes may migrate against thedirection of intended flow by forming a biofilm on a surface of theinside of urinary tubing and then said biofilm growing (migrating) inthe direction opposite of intended flow. Such surface growth of microbesmay generally be facilitated by the microbes attaching to a wettablesurface and then growing on the wettable surface. Thus, a second way tominimize undesirable microbe migration may be to inhibit the growth ofmicrobes on such surfaces of the tubing, especially wettable surfaces ofthe tubing. Another way to minimize microbe migration into the cathetermay be to block growth of microbes. Additionally, a fourth way tominimize undesirable microbe migration may be to inhibit attachment ofmicrobes on certain surfaces of the tubing.

Note, in this specification, “microbes” and “microbial” refers to avariety of micro-organisms which may comprise: bacteria, fungi (e.g.,yeast), viruses, protozoans, and the like. Microbes may be floatingfreely and/or suspended within a fluid, including fluid flowing withintubing. Microbes attached to a surface may form a colony comprising manyindividual microbial cells, i.e., a biofilm. The term, “biofilm” refersto at least one microbial cell that has attached itself to a surface,i.e., a biofilm may be a microbial colony of many microbial cellsattached to a surface.

The term, “antimicrobial” as used in this specification may refer tominimizing microbe migration in a direction opposite of intended flow.Functionally, this invention may provide for at least three mechanismsto this desired objective of providing an antimicrobial tubing andsystem, where those three mechanisms may be: (1) minimizing fluidbackflow (reflux); (2) minimizing microbe growth; (3) preventing microbegrowth into the catheter; and (4) minimizing microbe attachment tosurfaces, particularly to wettable surfaces. As used in thisspecification, the term “mitigate” may be synonymous with “abate” andmay include and encompasses the terms “prevent” and “inhibit.”

In some embodiments, a “system” as used in this specification maycomprise: a length of urinary extension tubing and at least oneconnector-with-integrated-check-valve that is connected to the length ofurinary extension tubing. In some embodiments, a system may comprise: acatheter, a length of urinary extension tubing, and at least oneconnector-with-integrated-check-valve that is connected to the length ofurinary extension tubing. In some embodiments, a system may comprise: acatheter, a length of urinary tubing, and a urine bag. In embodiments, asystem may comprise: a patient, a catheter, and a length of urinarytubing. In embodiments, a system may comprise: a patient, a catheter, alength of urinary tubing, and a urine bag. In some of the above systems,the system may further comprise at least oneconnector-with-integrated-check-valve that is connected to the length ofurinary extension tubing. In some of the above systems, the urinaryextension tubing may further comprise some additional structures (e.g.,check-valves), some with various antimicrobial structures and functions,as further disclosed and discussed below. In some embodiments, thesystem may be an anti-reflux extension tubing system.

This invention may comprise various embodiments of such tubing (e.g.,urinary tubing as disclosed herein). This invention may also comprisethe various systems, wherein such systems may comprise the tubing andthe catheter. In other words, the urinary tubing as the invention maynot comprise the catheter; but, the system as the invention may comprisethe catheter in some embodiments.

With respect to the catheter, such catheters may comprise bothindwelling and external catheters. Indwelling catheters may compriseFoley (i.e., inserted into the urethra), suprapubic (inserted intoabdomen or bladder), and nephrostomy (e.g., inserted in one or bothkidneys). External catheters may comprise condom catheters and femaleexternal collection systems.

With respect to the catheter, a connection between the catheter and theextension tubing may be located at the catheter's “exit port.” Such anexit port may also be referred to as a “drainage port.”

A “closed-system” may refer to how the system may be formed andmaintained isolated, i.e., kept physically separated, from componentsoutside of the system. It may be desirable to maintain such systems asclosed to help prevent infection, including urine backflow (reflux),from microbes entering the system and making their way into a patient.

A closed-system may be formed by maintaining the following connectedcomponents, with at least three points of connections (or points ofbeing sealed from outside influence): (1) a catheter properly connectedto a patient's urethra (or bladder or kidney); (2) a proper connectionbetween the catheter's exit port and a terminal end of urinary extensiontubing (e.g., a first terminal end); and (3) the remaining terminal end(e.g., second terminal end) of the urinary tubing being connected to aurine bag, or otherwise being sealed (e.g., taped, capped off or clampedshut). Each of these three points of connection may be a source ofbreach to render an otherwise closed-system into an open system. Forexample, if the catheter becomes disengaged from the patient's urethra,the system may then be open and microbes may then enter into the humanbody through the urethra. Another example: if the catheter exit portbecomes disengaged from a terminal end of tubing (e.g., a first terminalend), then microbes may enter the catheter into what may now be an opensystem. This connection of catheter and extension tubing may be taped toavoid unintended disconnect. With respect to the remaining terminal endof tubing (e.g., second terminal end), when such a terminal end isproperly connected to a urine bag, and the other two connections are inplace, then the system may be closed and no urine backflow (reflux) canenter the tubing due to the check valve (anti-reflux) in the urine bag.But unless some additional step or mechanism is utilized when the urinebag is disengaged from the urinary extension tubing, for example, toreplace the urine bag, the system may be open and microbes may thenenter the system through the second terminal end of the urinaryextension tubing because the remaining terminal end of tubing (e.g.,second terminal end) is now open to the external environment since themeans of prevention of urine backflow (reflux) is located inside theurine bag that has been removed. This invention, in its variousembodiments, may provide structure to maintain the system as closed evenwhen the tubing is disconnected from the urine bag, such as, but notlimited to use of a clamp or a second check-valve (that may be closed inits default operational configuration) inside of the urinary extensiontubing.

“Tubing” as used in this specification may have several differentmeanings. Functionally, tubing may be a conduit for transporting amaterial from one point to another point. For example, that material maybe a fluid, such as urine. Structurally, tubing in a traditional sensemay comprise an elongated hollow member (e.g., a cylinder) with at leastone length (with at least two terminal ends), an outside diameter, aninside diameter, and a wall thickness (defined by the difference inoutside and inside diameters). The length of tubing may generally belinear, but could form other shapes, such as a “Y” shape.

Tubing in this invention may further comprise additional structure suchas: various connectors, both with and without check-valves; variouscheck-valves, both with and without connectors; biofilm abaters; andantimicrobials coatings: of tubing surfaces, of connectors, and ofcheck-valves. Tubing as used in this specification may be flexibletubing, i.e., as opposed to rigid tubing. Tubing as used in thisspecification may be medical grade tubing. Medical tubing may besub-divided into urinary tubing, specifically extension tubing (e.g.,extension-tubing 9930), for the transport of urine from a catheter to aurine bag. Tubing as used herein may be described as flexible urinarytubing or flexible urinary extension tubing (e.g., extension-tubing9930). Tubing may run from an exit port of the catheter directly to theurine bag, i.e., a primary length of tubing. Tubing as used herein maybe described as flexible indwelling catheter tubing (e.g.,catheter-tubing 9920). The length of tubing may vary to accommodate aleg bag or longer to accommodate the distance between the catheter (orpatient) and a bed bag. However, the length of tubing may bepredetermined.

In various embodiments, tubing may be substantially constructed ofvarious polymers. The polymers may be suitable for tubing extrusion,injection molding, ultrasonic bonding, solvent bonding, heat welding,and/or chemical adhesives. For example, tubing in the traditional senseof an elongated hollow member with an outside and inside diameter may beefficiently manufactured by extrusion into various lengths. Whereas,tubing in the traditional sense may also be injection molded, but wheresuch a means of manufacture may be more expensive and with limitedavailable lengths compared to extrusion methods of manufacture.Additional, structural components of the tubing (e.g., connectors withor without check-valves, check-valves with or without connectors,biofilm abaters, and coupling sleeves) may be substantially constructedusing injection molding.

Such polymers may comprise: urethane (including polyurethanes), rubber(with or without latex), polyvinyl chloride (PVC), silicone,polyethylene (low density and high density), nylon, fluropolymers,polypropylene, acrylonitrile-butadiene styrene (ABS), polycarbonate,acrylic, and/or the like. PVC may be the most common material ofconstruction for flexible medical urinary extension tubing.

With respect to use of “substantially constructed of” in the abovematerials discussion, such phrasing may be used because variousembodiments of tubing may also include some additional non-polymermaterials. For example, in various embodiments there may beantimicrobial coatings to certain regions of the tubing, to connectors,to check-valves and/or to biofilm abaters. There may be rigid tosemi-rigid plastics used in the check-valves. There may some metal(e.g., stainless steel) used in some components, for example, somecheck-valves may employ springs made of metal. Biofilm abaters may beconstructed of entirely of silver (or silver alloy) or coated withsilver (or silver alloy). In some embodiments, adhesives tapes (as atype of coupling sleeve) may also be a component of the tubing. Somesolvents may be used for solvent bonding and chemical adhesives may alsobe utilized in assembly.

Polymer formulations may also comprise other ingredients which increasethe cured polymers antimicrobial properties, for example and withoutlimiting the scope of the present invention, including silver within thepolymer formulation.

More than one type of polymer may be used within a given embodiment oftubing. For example, and without limiting the scope of the presentinvention, in various embodiments, the elongated member of the tubingmay be substantially constructed of PVC, while a connector, with orwithout check-valve, may be substantially constructed of HDPE (highdensity polyethylene) or polycarbonate.

With respect to materials of construction because the tubing may bemedical grade tubing, the choice of materials may be limited to polymerswhich may be manufactured aseptically (e.g., in clean rooms) and thensubsequently sterilized without the tubing significantly degrading.Common sterilization methods include steam sterilization via autoclaves,gamma irradiation, ultraviolet exposure, and ethylene oxide (EtO) gasexposure. Gamma irradiation tends to render materials more brittle andsteam sterilization may leave behind water vapor which condenses and mayfacilitate microbial contamination subsequent to the sterilization. Eachof the above listed polymers may have various formulations that whencured may appropriately be sterilized by each of these sterilizationmethods.

Choice of materials may also be limited to polymers which may be fieldsterilized or sanitized by exposure to various chemicals, such asalcohol (e.g., isopropyl alcohol), bleach, and peroxides. (Fieldsterilization or sanitization may be sterilization or sanitization doneby the user of the product, such as a medical practitioner, as opposedto sterilization that occurs as a step in the manufacturing process.)

Note, with respect to the materials of construction, it is not desirednor intended to thereby unnecessarily limit the present invention byreason of such restricted disclosure.

Now turning to a general discussion of tubing structure, which isfurther detailed in the discussion of the various figures. In variousembodiments, the tubing may comprise a first terminal end and a secondterminal end, such that the first terminal end may be disposed oppositeof the second terminal end, e.g. located at longitudinal opposing ends.Tubing may be bounded by the first terminal end and the second terminalend.

In some embodiments, the tubing may comprise a wettable region, whichmay comprise a surface which is wetted when a fluid flows within thetubing. For example, and without limiting the scope of the presentinvention, common wettable regions may comprise the interior surfaces ofthe tubing which may comprise an inside diameter of the tubing along acorresponding length of the tubing. Additional wettable regions of thetubing may comprise various interior surfaces of various connectors,with and without check-valves, as well as check-valves withoutconnectors.

An outside diameter of the tubing is generally not a wettable region nora wettable surface. However, the outside diameter regions immediatelyproximal of the first terminal end and the second terminal end may bephysically so close to wettable regions of the tubing, that such outsidediameter regions may also be ideal candidate regions for treating withan antimicrobial coating.

In some embodiments, the tubing (e.g., extension tubing) may comprise ameans for minimizing microbial migration in a direction opposite ofintended flow. The means for minimizing microbial migration in thedirection opposite of intended flow may be selected from one or more ofthe group comprising: (1) at least one check-valve; (2) at least onebiofilm abater; (3) and the wettable region treated with anantimicrobial coating. For example, and without limiting the scope ofthe present invention, the tubing may comprise one check-valve which hasbeen treated with an antimicrobial coating (or one check-valve with noantimicrobial coating). Any combination of these three means may belocated within the tubing and/or at one or both of the terminal ends(first terminal end and second terminal end). Each of these threeantimicrobial means for minimizing microbial migration in a directionopposite of intended flow is briefly discussed below.

Check-valves as used in this specification refer to devices which may beintended to allow fluid flow in only one direction. Check-valves mayaccomplish this function using a variety of means well known in the art,such as utilizing springs with balls, flaps (diaphragms), one-way gates(swing and/or tilt), duckbills, and the like. A given check-valve maygenerally have at least one inlet and at least one outlet, where theinlet and the outlet are generally points of connection to thecheck-valve. Check-valves may be in an open configuration when no backpressure is applied to the check-valve, permitting flow in the desireddirection. Check-valve locations in some embodiments may be positionedat either terminal end of the tubing, both terminal ends of the tubing,or in between the two terminal ends of the tubing.

For example, a check-valve used in urinary tubing, as described anddisclosed in this specification, permits urine flow in the desireddirection when the upstream urine pressure exceeds the check-valve'sresting state and opens the check-valve. Upstream urine pressure may becreated naturally from the patient urinating, or may arise by virtue ofa static head, i.e. the height of urine in tubing (and catheter)upstream of a check-valve, where the greater the height of urine, thegreater the urine pressure (greater the static head of urine pressure).Such upstream urine pressure created by a static head of urine is withrespect to a gravitational pull, i.e. urine like all liquid fluids flowsdownhill. If the exit end of urinary tubing is raised above the entrypoint of urinary tubing, any urine within the urinary tubing may beencouraged to flow backwards, against the intended flow, because byraising the exit end above the entry end greater downstream urinepressure has been created by a static head of urine. A check-valve inproper place (e.g., not installed backwards) within the tubing mayprevent such backflow (reflux) because the check-valve may be designedto be closed when the downstream pressure exceeds the upstream pressure.In some embodiments, such a check-valve may be normally closed, onlyopening for normal urine flow in the direction of intended flow.

Note, the locational identifiers of “downstream” and “upstream” may bein reference to the direction of intended flow, i.e., intended flowflows from the upstream to the downstream. Such locational identifiesmay also be in reference to some third point in between the upstream anddownstream locations, such as a check-valve.

Now turning to another antimicrobial means for minimizing microbialmigration in a direction opposite of intended flow, the use of a biofilmabater within the tubing. As used in this specification, the biofilmabater is a device which may prevent or minimize biofilm movement(migration or growth) in the direction opposite of intended flow.Because biofilm movement (e.g., migration or growth) occurs more readilyon wettable regions within the tubing, particularly regions which arecurrently wet, then the biofilm abater may be located within the tubingso as to prevent or minimize biofilm movement in the direction oppositeof intended flow.

In some embodiments, biofilm abaters may circumscribe an inside diameterof the tubing. Whereas, in some embodiments, biofilm abaters maycircumscribe an outside diameter of the tubing.

Biofilm abaters may operate in several ways, which are not mutuallyexclusive. First, the biofilm abater may inhibit microbe growth.Secondly, the biofilm abater may inhibit microbe attachment to a surface(generally a wettable surface). Inhibiting growth may involveinterfering with a microbe's cellular processes, such as cellularreplication or cell-wall development. While inhibiting attachment mayinvolve creating a surface substrate that is molecularly too slipperyfor a microbe to attach to. Thirdly, biofilm abater may be a closedcheck-valve when urine is not flowing, thereby providing a physicalbarrier preventing biofilm from entering the catheter through thecheck-valve.

In some mechanisms of operation, growth inhibiting or attachmentinhibiting, the biofilm abater may take on the structural and geometricproperties of a ring fitted snuggly within the tubing. The biofilmabater may comprise a ring. The ring may comprise an outside diameterthat may be in direct physical contact with the tubing's insidediameter, such that the tubing's inside diameter frictionally grips thering's outside diameter. Such a ring structure may also comprise aninside diameter, configured to permit fluid flow. This point of directphysical contact between the ring and the tubing may also be such thatno fluid is permitted to flow between the ring's outside diameter andthe tubing's inside diameter. All fluid flow may be directed through theinside diameter of the ring.

Such a ring may inhibit biofilm growth on the wettable surfaces of thering, such as the ring's inside diameter, by the ring's wettablesurfaces comprising an antimicrobial property that inhibits growth. Forexample, in various embodiments, the ring may be made entirely of silver(or a silver alloy) or the ring may be coated with silver (or silveralloy). Silver, in both metallic form (and alloys) and silver saltforms, is well known within the art of comprising antimicrobialproperties which inhibit microbial growth and may actually killmicrobes. The biofilm abater which may comprise the ring, may have apredetermined measureable length and width, wherein the ring maycomprise silver or a silver coating may inhibit biofilm migration acrossthe inside diameter of such a ring. Such a ring may be entirelyconstructed of metallic silver or various external surfaces of the ringmay be coated with silver. Such antimicrobial properties are not limitedto silver and silver coatings.

Such a ring structure may inhibit biofilm attachment to the wettablesurfaces of the ring, such as the ring's inside diameter, by the ring'swettable surfaces comprising an antimicrobial property that inhibitsattachment. In various embodiment, the ring's wettable surfaces, such asthe ring's inside diameter may be coated with a material providinganti-attachment properties. Anti-attachment may be accomplished byforming a surface that is molecularly smooth (molecularly slippery),such that there is no molecular geometry for microbes to attach to. Forexample, surfaces may be treated with a Teflon® coating, which is knownto result in a slippery surface that reduces microbe attachment. Otherchemicals may also be used to treat surfaces yielding a molecularlysmooth surface that microbes find difficult to attach to. Such coatingtreatments may be applied to materials of construction typical fortubing, various connectors, and check-valves, such as silicone, PVC(polyvinylchloride), PU (polyurethane), and the like.

In various embodiments, a biofilm abater may comprise a ring, which maycomprise a molecularly smooth coating of the ring's wettable surfaces,which may then inhibit biofilm migration across the inside diameter ofsuch a ring because the microbes find difficulty in attaching to suchcoated regions. In various embodiments, the ring's outside diameter maynot be treated with the molecularly smooth coating, as such a coatingmay interfere with the tubing's inside diameter frictionally grippingthe ring's outside diameter.

Now turning to the third antimicrobial means for minimizing microbialmigration in a direction opposite of intended flow, which may be regionsof the tubing which may comprise an antimicrobial coating, where suchregions are predominantly wettable regions. Such coated regions oftubing may function in an equivalent manner as the biofilm abaterembodiments discussed above, but instead of coating a separate componentlike the biofilm abater's ring, here a region or all of the tubingmaterial of construction may be coated with one of the anti-microbialcoatings. As noted above the antimicrobial coatings may either inhibitbiofilm growth across the treated region or the antimicrobial coatingmay inhibit attachment to the coated region. Or the antimicrobialtreated region may comprise both functions. For example, in variousembodiments, the coated region may comprise a silver coating which mayinhibit biofilm growth across the coated region. Whereas, in otherembodiments, the coated region may comprise a molecularly smooth coatingwhich may inhibit biofilm attachment to the coated region and thusinhibit biofilm migration across the coated region.

Coated regions may comprise a given length of the tubing's insidediameter, such that the coated region completely circumscribes thetubing's inside diameter for that given length, thus presenting auniform barrier to biofilm migration (movement). Wettable treatedregions may also comprise various interior surfaces of variousconnectors, with and without check-valves, as well as check-valveswithout connectors. For example, and without limiting the scope of thepresent invention, in various embodiments a check-valve' s interiorwettable surfaces may be coated with the antimicrobial coating.

In various embodiments, a coated region may comprise a region of outsidediameter tubing that is immediately proximal of the first terminal endand/or of the second terminal end, as such outside diameter regionsalthough are generally non-wettable regions, they are regions which arenevertheless prone to contaminating urinary tubing due to their closeproximity and access to inside diameter wettable regions of the tubing.Such a distance of “immediately proximal” may be up to and including 8inches from either terminal end (first terminal and/or second terminalend). In some embodiments, an entirety of the tubing may be coated withthe antimicrobial material.

In some embodiments, the tubing material of construction itself, i.e.,not just the surface regions, may have antimicrobial ingredients addedinto the materials formulation to yield a cured material that exhibitsantimicrobial properties.

Each of these means for minimizing microbial migration in the directionopposite of intended flow may be located within the tubing at variouslocations along the tubing's length, at the tubing's first terminal end,or at the tubing's second terminal end.

In the following discussion that addresses a number of embodiments andapplications of the present invention, reference is made to theaccompanying figures (drawings) that form a part thereof, wheredepictions are made, by way of illustration, of specific embodiments inwhich the invention may be practiced. It is to be understood that otherembodiments may be utilized and changes may be made without departingfrom the scope of the invention.

The FIG. 1 series of figures includes FIG. 1A, FIG. 1B, and FIG. 1C. TheFIG. 1 series of figures may serve two functions: (1) to place thetubing invention into context of being connected to a catheter at oneend and a urine bag at an opposing end; and (2) to depict the inventivesystem, wherein the system may comprise the inventive tubing, as well asa catheter.

FIG. 1A depicts a tubing 100 connected at one end to a catheter 9915 andat the other end to a urine leg bag 9901 a, shown from a frontal view.Catheter 9915 as shown may be properly connected to patient 9910, i.e.,by proper partial insertion into patient 9910's urethra, i.e., catheter9915 may be an indwelling catheter, such as a Foley catheter. FIG. 1Bdepicts tubing 100 connected at one end to catheter 9915 and at theother end to a urine bed bag 9901 b, shown from a longitudinal sideview. Here catheter 9915 may be properly connected to patient 9910 thatis lying down or otherwise occupying a bed. FIG. 1C depicts anembodiment 200 of tubing 100 connected at one terminal end, a firstterminal end 101 to catheter 9915, and at the other terminal end, asecond terminal end 102 to urine bag 9901, shown from a top view.

FIG. 2 depicts embodiment 200 of tubing 100 comprising a connectorintegrated with check-valve 205, where first terminal end 101 of tubing100 may be connected to an exit port 9917 of catheter 9915 via connectorintegrated with check-valve 205, shown from a top view.

Note in FIG. 2 the entire catheter 9915 and the entire tubing 100 may bedepicted; while patient 9910 and urine bag 9901 are not depicted.Whereas, in FIG. 2A, and FIG. 2B the focus may be depicting theconnection where tubing 100 may be connected to catheter 9915, which mayutilize connector integrated with check-valve 205 to connect exit port9917 to first terminal end 101 of tubing 100.

In terms of tubing 100 overall length, such an overall length may beshort to accommodate use with leg bag 9901 a. For example, and withoutlimiting the scope of the present invention, such an overall length oftubing 100 may be from two inches to seven inches; or longer or shorterin other embodiments. In other embodiments, overall length may betwenty-four inches or longer to accommodate use with bed bag 9901 b.

FIG. 2A depicts embodiment 200 of tubing 100, shown from a close uplongitudinal cross-sectional view of the connection. FIG. 2B depictsembodiment 201 of tubing 100 with an addition of tape 206 b wrappingaround the connection between catheter 9915 and tubing 100, shown from alongitudinal cross-sectional view.

First general structure which may be common to both embodiment 200 and201 is discussed, followed by additional structure of embodiment 201.Embodiment 200 of tubing 100 may comprise: first terminal end 101,second terminal end 102, and connector integrated with check-valve 205.First terminal end 101 may longitudinally oppose second terminal 102.Connector integrated with check-valve 205 may be a single article ofmanufacture. Connector integrated with check-valve 205 may be located atfirst terminal end 101 and may be configured to connect tubing 100 tocatheter 9915. The connection between catheter 9915 and tubing 100 maybe formed by connecting first terminal end 101 to catheter exit port9917 via connector with check-valve 205 (wherein that connector andcheck-valve are integral with respect to each other). Connector withcheck-valve 205 may comprise two opposing ends, where one end may besized to frictionally and removably couple with an inside diameter offirst terminal end 101 and where the other end may likewise be sized tofrictionally and removably couple with an inside diameter of exit port9917. And the check-valve component of connector integrated withcheck-valve 205 may be located internally within connector integratedwith check-valve 205, and may prevent urine backflow (reflux), whichthen serves as one example of a means for minimizing microbial migrationin a direction opposite of intended flow.

In various embodiments, there may be more than one connector as acomponent of tubing 100. Additional such connectors may or may notinclude a check-valve. In various embodiments, there may be other meansfor minimizing microbial migration in a direction opposite of intendedflow. For example, there may be more than one check-valve. The means forminimizing microbial migration in the direction opposite of intendedflow may be selected from one or more of the group comprising at leastone check-valve (205, 308, and 605), at least one biofilm abater 613,and a region treated with an antimicrobial coating (e.g., such as region622). The region of tubing 100 may comprise a surface which may bewetted by fluid flowing within tubing 100, such as urine flowingdownstream. Such means for minimizing microbial migration in thedirection opposite of intended flow may be located in tubing 100, atfirst terminal end 101, or at second terminal end 102. See the FIG. 6Fdiscussion below for an embodiment including at least two check-valves(205 and 605). Biofilm abaters 613 are discussed in the FIG. 6B, FIG.6C, and FIG. 6D discussions. And see the FIG. 6E discussion below for anembodiment including wettable region treated with an antimicrobialcoating.

As depicted in FIG. 2B, embodiment 201 of tubing 100 may comprise theadditional component of tape 206 b. Connector integrated withcheck-valve 205 while connected to first terminal end 101 may comprise alength of tape 206 b wrapped around the connection between the firstterminal end 101 and the exit port 9917 to prevent the connection frombecoming disengaged which the minimizes ingress of contaminants, such asmicrobes, into tubing 100. Securing the connection with tape 206 bfacilitates maintaining a closed-system. In various embodiments, whentape 206 b has been wrapped around the connection, tape 206 b maycircumscribe a portion of terminal end 101 and a portion of exit port9917.

In various embodiments, tape 206 b may comprise a bonding means for tape206 b gripping outside surfaces of exit port 9917 and first terminal end101. For example, such a bonding means may be formed by at least oneside of tape 206 b having an adhesive property.

Tape 206 b may be a sub-category of the broader category referred to asa “coupling sleeves” 206 within this specification. That is, couplingsleeve 206 may comprise tape 206 b. See the discussion of the FIG. 4 andFIG. 5 series of figures for further details regarding coupling sleeve206.

In various embodiments, tape 206 b may comprise a color on a side facinga viewer, where the purpose of such a color may be to warn a medicalpractitioner that terminal end 101 should not be disengaged from exitport 9917, while catheter 9915 may be inserted into patient 9910'surethra without some precaution taken to prevent opening of theclosed-system. For example, and without limiting the scope of thepresent invention, such a color might be a bright orange, yellow, orred; and may have a written warning on the tape. Product literature andmedia (e.g., product inserts, white papers, website media, etc.) mayinclude instructions as to the warning not to disengage such coloredtape 206 b. Tape 206 b may serve at least two functions: (1) to preventopening of an otherwise closed-system; and (2) to warn against breachingan otherwise closed-system.

Now turning to the FIG. 3 series of figures. The FIG. 3 series offigures may be generally the same as the FIG. 2 series of figures, withthe exception that connector integrated with check-valve 205 may bereplaced with a connector 307 and a check-valve 308. FIG. 3A depictsembodiment 300 of tubing 100 which may comprise connector 307 coupled tonon-integral check-valve 308, where first terminal end 101 of tubing 100may be connected to exit port 9917 of catheter 9915 via connector 307,wherein connector 307 may be coupled to non-integral check-valve 308,shown from a longitudinal cross-sectional view.

In embodiment 300 (and 301), tubing 100 may comprise at least oneconnector 307 coupled to check-valve 308, where connector 307 andcheck-valve 308 may be separate articles of manufacture which may becoupled together in tubing 100. Connector 307 with coupled check-valve308 may be connected to first terminal end 101 and may be configured toconnect first terminal end 101 to exit port 9917 of catheter 9915.

In various embodiments, such a coupling of connector 307 to check-valve308 may be permanent. Whereas, in other embodiments, such a coupling maybe removable, i.e., after coupling, check-valve 308 may be disengagedfrom connector 307.

Various means may be used to couple connector 307 to non-integralcheck-valve 308. Connector 307 may frictionally hold check-valve 308.Check-valve 308 may be snapped into connector 307. Connector 307 may besolvent bonded to check-valve 308, when both components are constructedof appropriate polymers which may be solvent bonded together. Connector307 may be ultrasonically welded to check-valve 308. Connector 307 maybe glued to check-valve 308 using an appropriate adhesive (e.g., via amedical grade cyanoacrylate).

FIG. 3B depicts a similar embodiment shown in FIG. 2B, with theinclusion of tape 206 b wrapping around the connection. FIG. 3B depictsembodiment 301 of tubing 100 with an addition of tape 206 b wrapping theconnection between catheter 9915 and tubing 100, shown from alongitudinal cross-sectional view.

The FIG. 4 and FIG. 5 series of figures may introduce tubing embodiments(400, 401, 500, and 501) where a single length of tubing 100 may be cutinto two smaller pieces of tubing and then joined back together via aconnector with a check-valve to form a single length of tubing 100. Suchembodiments (400, 401, 500, and 501) may then provide for the means forminimizing microbial migration in a direction opposite of intended flowto be located within tubing 100; as opposed to locating the means forminimizing microbial migration in a direction opposite of intended flowat either first terminal end 101 (e.g. as shown in the FIG. 2 and FIG. 3series of figures) and/or at second terminal end 102.

Such embodiments (400, 401, 500, and 501) may not be mutually exclusivewith locating the means for minimizing microbial migration in adirection opposite of intended flow at either first terminal end 101and/or second terminal end 102. Embodiments (400, 401, 500, and 501) mayalso comprise other means for minimizing microbial migration in adirection opposite of intended flow which may be located at either firstterminal end 101 and/or second terminal end 102.

FIG. 4 depicts embodiment 400 of tubing 100 where tubing 100 may besub-divided at a joint into two smaller tubes (409 and 410) such thatconnector integrated with check-valve 205 may be inserted between thetwo smaller tubes (409 and 410) to join the two smaller tubes (409 and410), which then form a complete length of tubing 100, shown from a topview.

In embodiment 400, tubing 100 may comprise: first tube 409, second tube410, a joint, and connector integrated with check-valve 205. First tube409 may comprise first terminal end 101 and a third terminal end 411.First terminal end 101 longitudinally opposes third terminal end 411.Second tube 410 may comprise second terminal end 102 and a fourthterminal end 412. Second terminal end 102 may longitudinally opposefourth terminal end 412. As noted above, first terminal end 101 maylongitudinally oppose second terminal end 102. The joint may be madebetween first tube 409 and second tube 410 to form tubing 100 by usingconnector integrated with check-valve 205 to connect third terminal end411 to fourth terminal end 412.

As used in this specification, “joint” refers to joining first tube 409to second tube 410; while “connection” may refer to connecting tubing100 to catheter 9915 or to connecting tubing 100 to urine bag 9901.

In terms of tubing 400, the single length may be short to accommodateuse with leg bag 9901 a. For example, and without limiting the scope ofthe present invention, single length of tubing 100 may be from about twoinches to seven inches. In some embodiments, the single length may beabout twenty-four inches or longer to accommodate use with bed bag 9901b. In some embodiments, the single length may be less than about oneinch to a desired length to accommodate attachment to various types ofbags. Wherein “about” in this paragraph may be plus or minus 0.25 of aninch

FIG. 4A depicts embodiment 400 of tubing 100, shown from a longitudinalcross-sectional view focusing on the joint between first tube 409 andsecond tube 410 that may be formed by connector integrated withcheck-valve 205 connecting third terminal end 411 to fourth terminal end412.

FIG. 4B depicts embodiment 401 of tubing 100 where the joint may becircumscribed by coupling sleeve 206, shown from a longitudinalcross-sectional view. Tubing 100 may comprise coupling sleeve 206 whichmay circumscribe the joint between third terminal end 411 and fourthterminal end 412. Coupling sleeve 206 may be configured to grip thejoint, such that coupling sleeve 206 translation along tubing 100 may beminimized, i.e., coupling sleeve 206 may not freely slide along thelongitude of tubing 100. In some embodiments, such gripping may beaccomplished by coupling sleeve 206 comprising geometry to frictionallygrip tubing 100. For example, coupling sleeve 206 may comprise an insidediameter which may be sized to be substantially the same as outsidediameter 104 of tubing 100, such that there may be friction betweencoupling sleeve 206 and tubing 100 when tubing 100 may be inserted intothe inside diameter of coupling sleeve 206. In other embodiments,coupling sleeve 206 may grip the joint by the bonding means. The bondingmeans may be selected from one or more of the group comprising heatwelding, ultrasonic welding, solvent bonding, chemical adhesives(including adhesive tape), and the like. Coupling sleeve 206 may bebonded to outside diameter 104 of tubing 100 in a region proximal toeach side of the joint to prevent the joint from becoming disengagedwhich minimizes ingress of contaminants, such as microbes, into tubing100.

Coupling sleeve 206 may comprise a length of tape 206 b wrapped aroundthe joint to prevent the joint from becoming disengaged which minimizesingress of contaminants, such as microbes, into the tubing 100. Tape 206b may comprise a color, e.g., a bright color as in red, to serve as awarning to a viewer, such as a medical practitioner, that the jointshould not be opened and disengaged.

Now turning to the FIG. 5 series of figures. The FIG. 5 series offigures may be generally the same as the FIG. 4 series of figures, withthe exception that connector integrated with check-valve 205 may bereplaced with connector 307 and check-valve 308.

FIG. 5A depicts embodiment 500 of tubing 100 where tubing 100 may besub-divided at the joint into two smaller tubes (409 and 410) such thatconnector 307 with non-integral check-valve 308 may be inserted betweenthe two smaller tubes (409 and 410) to join the two smaller tubes (409and 410), which then may form tubing 100, shown from a longitudinalcross-sectional view.

The details regarding the coupling of connector 307 to check-valve 308were first discussed above under the FIG. 3A discussion and thatdiscussion may apply here for embodiment 500 depicted in FIG. 5A and ofembodiment 501 depicted in FIG. 5B.

FIG. 5B depicts embodiment 501 of tubing 100 of FIG. 5A, where the jointmay be circumscribed by coupling sleeve 206, shown from a longitudinalcross-sectional view. The details regarding coupling sleeve 206 werediscussed above under the FIG. 4B discussion and that discussion mayapply here for embodiment 501.

Now turning to the FIG. 6 series of tubing 100 embodiments. The FIG. 6series of figures addresses at least seven distinct embodiments, whichmay be combined into various embodiments, also within the scope of thepresent invention.

FIG. 6A depicts embodiment 601 of tubing 100 where check-valve 605 mayhave been inserted into tubing 100 by pushing the check-valve into adesired location, shown from a longitudinal cross-sectional view.

In embodiment 601, tubing 100 may comprise check-valve 605. Check-valve605 may be assembled into tubing 100 by pushing check-valve 605 insidetubing 100 to a desired location along a length of tubing 100 such thattubing 100 may frictionally grip check-valve 605 to maintain the desiredlocation, while also forming a complete seal between a periphery ofcheck-valve 605 (e.g., an outside diameter of check-valve 605) andinside of tubing 100 (e.g., an inside diameter 103 of tubing 100) wherethe check-valve 605 may be positioned. Check-valve 605 may comprise anoutside diameter, as part of check-valve 605's periphery, which may besubstantially similar to inside diameter 103 of tubing 100, such thatcheck-valve 605 may not translate (slide) within tubing 100 unless aforce may be applied to overcome the frictional gripping force. Thenature of such frictional gripping may be to form a seal between theoutside diameter of check-valve 605 with inside diameter 103 of tubing100, such that fluid flowing through tubing 100 may not pass between theoutside diameter of check-valve 605 and inside diameter 103 of tubing100. Such a complete seal may also be formed with the aid of one or moreo-rings (or gaskets) circumscribing outside diameter of check-valve 605.

In various embodiments, tubing 100 may first be heated to increase itspliability and to expand tubing 100, then subsequently check-valve 605may be pushed inside tubing 100 to the desired location. Upon tubing 100cooling, tubing 100 may contract and increase frictional grippingbetween tubing 100 and check-valve 605.

In some embodiments, check-valve 605 may also be positionally fixedwithin tubing 100 by ultrasonically welding, solvent bonding, and by useof chemical adhesives.

While only one check-valve 605 may be depicted in FIG. 6A, such a methodof positioning check-valves within tubing 100 may be used to place aplurality of check-valves (such as check-valve 605) within tubing 100.

Notes regarding check-valve 605 and check-valve 308: Check-valve 308 mayrefer to a check-valve that may be configured to couple with connector307. Check-valve 605 may not necessarily include such a furtherlimitation.

FIG. 6B, FIG. 6C, and FIG. 6D address embodiments where tubing 100 maycomprise one or more biofilm abaters 613, which may reside within tubing100.

FIG. 6B depicts embodiment 602 of tubing 100 with biofilm abater 613inserted into tubing 100, shown from a longitudinal cross-sectionalview. FIG. 6C depicts the embodiment of FIG. 6B, but shown from a topcross-sectional view.

In embodiment 602, tubing 100 may comprise one or more biofilm abater613. Each biofilm abater 613 may comprise a ring. The ring may havestructure which comprises an inside diameter, outside diameter 613 a,and a thickness which may be defined by the difference between outsidediameter 613 a and the inside diameter. Outside diameter 613 a may beconfigured to fit within inside diameter 103 of tubing 100. Outsidediameter 613 a may be frictionally held in place in a desired locationwithin inside diameter 103 of tubing 100. Such frictional gripping maybe accomplished by outside diameter 613 a being substantially similar,in terms of dimension, to inside diameter 103 of tubing 100. The ring ofbiofilm abater 613 may be in a desired conformation within tubing 100,such that a plane of outside diameter 613 a may be perpendicular to alongitude of the tubing 100. The ring of biofilm abater 613 may comprisea longitude, wherein the longitude of the ring of biofilm abater 613 maybe parallel to the longitude of tubing 100. The longitude of tubing 100may include a length, and the longitude of the ring of biofilm abater613 may also include a length, wherein the length of tubing 100 may begreater than the length of the ring of biofilm abater 613.

The ring of biofilm abater 613 may include surface areas covering theexternal surfaces of the ring. The ring of biofilm abater 613 maycomprise an antimicrobial coating, covering surface areas of the ring.In various embodiments, the wettable surface areas of the ring ofbiofilm abater 613 may be coated with the antimicrobial coating. Outsidediameter 613 a may not be coated with the antimicrobial coating. In someembodiments, biofilm abater 613 may butt against a connector and/orcheck-valve.

As noted above in the general discussion of biofilm abaters precedingthe figures discussion, such an antimicrobial coating may preventmicrobial biofilms from growing across the surface areas of the ringwhich have treated with such an antimicrobial coating by inhibitingmicrobial growth or by inhibiting microbial attachment. For example, andwithout limiting the scope of the present invention, such anantimicrobial coating may comprise silver (or a silver alloy) to inhibitgrowth. Antimicrobial properties may be achieved where the entire ringof biofilm abater 613 may be constructed of silver, a silver alloy, oranother abating material. In other embodiments, such an antimicrobialcoating may comprise a molecularly smooth chemical coating yielding amolecularly smooth surface which may reduce the ability of microbes toattached to the coated region.

FIG. 6D depicts embodiment 603 of tubing 100 with check-valve 605 andwith bio-film abater 613 inserted into tubing 100 upstream ofcheck-valve 605, shown from a longitudinal cross-sectional view. FIG. 6Din comparison to FIG. 6B and FIG. 6C, includes an additional componentof check-valve 605. The reason for such a spatial relationship may be asfollows: an intended function of check-valve 605 may be to prevent urinebackflow (reflux) which may then prevent microbes free floating and/orin suspension in urine from travelling towards patient 9910 using tubing100 as a conduit; however, such a check-valve may not prevent biofilmgrowth migration (movement) towards patient 9901; and so biofilm abater613 may be installed upstream of check-valve 605 to abate biofilmmigration.

In other embodiments, such check-valves (e.g., 205, 307, and 605) maycomprise both the backflow prevention function and biofilm migrationprevent function by the check-valve having its wettable surfaces coatedwith the antimicrobial coating or means to be closed when urine is notflowing through the check valve.

FIG. 6E depicts embodiment 621 of tubing 100 where inside surface region622 of tubing 100 may comprise the antimicrobial coating, and whereinside surface region 622 may be upstream of check-valve 605, shown froma longitudinal cross-sectional view. Embodiment 621 depicted in FIG. 6Emay be similar to embodiment 603 depicted in FIG. 6D, except here inFIG. 6E biofilm abater 613 may be replaced with inside surface region622.

Inside surface region 622 may be a region of antimicrobial coating.Inside surface region 622 may be an example of the wetted region treatedwith the antimicrobial coating. As a wetted region treated with theantimicrobial coating, there may be a reduced likelihood of a microbialbiofilm migrating across the wetted region treated with theantimicrobial coating. Inside surface region 622 may comprise geometryof circumscribing inside diameter 103 of tubing 100 for a sub-length 622a that may be less than a total length of the tubing 100. In someembodiments, sub-length 622 a may be a substantially similar length asthe total length of the tubing 100. Inside surface region 622 may belocated upstream of check-valve 605.

In various embodiments, the wetted region treated with the antimicrobialcoating may be selected from one or more of the group comprising atleast one connector (e.g., 307), at least one check-valve (e.g., 205,308, and/or 605), at least one biofilm abater 613, and/or inside surfaceregion 622 of tubing 100. For example, and without limiting the scope ofthe present invention, any of the check-valves (205, 308, 605) depictedin the various figures may have been treated with the antimicrobialcoating, particularly on the wettable surfaces. Likewise, any of theconnectors (205 and 307) depicted in the various figures may have beentreated with the antimicrobial coating, particularly on the wettablesurfaces.

Note while more than one connector with or without check-valve,check-valve with or without connector, biofilm abater 613, and insidesurface region 622 may be employed in various embodiments, there is apractical limitation to the number of such components which may beemployed in any given embodiment. Such a numerical limitation arises inpart because tubing 100 in any given application must have a finitetotal length, which is generally the length necessary to run fromcatheter 9915 to urine bag 9901, including some length for slack andease of patient 9910 movement. Such a numerical limitation may arise inthe case of check-valves because each additional check-valve mayincrease the necessary fluid pressure to flow through all check-valvesinstalled in serial fashion and the fluid pressure itself may a maximumpressure created by patient 9910 urinating and/or by any static head ofurine within catheter 9915 and tubing 100. As the number of check-valvesincreases the greater the required pressure is needed to flow through aserial installment of check-valves.

FIG. 6F depicts embodiment 651 of tubing 100 where there are twocheck-valves (205 and 605) inserted into tubing 100, in serial fashion(i.e., one upstream and one downstream with respect to each other),shown from a longitudinal cross-sectional view. Connector integratedwith check-valve 205 may be used to connect first terminal end 101 toexit port 9917 of catheter 9915. Check-valve 605 may be inserted andpushed into the desired location within tubing 100. In variousembodiments, either one or both check-valves may also comprise theantimicrobial coating, particularly on wettable surfaces.

FIG. 6G depicts embodiment 631 of tubing 100 which may comprise samplingport 632, shown from a longitudinal cross-sectional view. In embodiment631, tubing 100 may comprise sampling port 632. Sampling port 632 may belocated a linear distance 633 from second terminal end 102. Samplingport 632 may be configured to receive a syringe for the purpose of ataking a sample of fluid from within tubing 100. For example, andwithout limiting the scope of the present invention, a medicalpractitioner might take a urine sample from sampling port 632 in orderto determine the microbial load present within the urine or for variousother purposes.

In various embodiments, sampling port 632 may be located closer tosecond terminal 102 than to first terminal end 101. Linear distance 633may be 0.25 to 7.00 inches in some embodiments and other distances inother embodiments. Such a location may serve two purposes. First byplacing sampling port 632 closer to second terminal end 102 (and fartherfrom first terminal end 101), there may be less interference withpatient 9910's comfort when urine samples are withdrawn from tubing 100,as movement of tubing 100 at the second terminal end 102 may be lesslikely to be communicated up tubing 100 to catheter 9915. Secondly,taking urine samples from tubing 100 may constitute a technical, albeitintermittent, breach of what may have otherwise been a closed-system.Withdrawing urine samples from tubing 100 may increase the likelihood ofintroducing unwanted contaminants, such as microbes, into tubing 100.Placing sampling port 632 farther away from catheter 9915 and patient9910, there may be a greater likelihood of minimizing any suchcontaminant reaching catheter 9915 or patient 9910.

FIG. 6H depicts embodiment 641 of tubing 100 which may comprise agraphical indicator 642, which may indicate which end of tubing 100 maybe detached from urine bag 9901, shown from a longitudinalcross-sectional view. Second terminal end 102 may comprise graphicalindicator 642 to indicate which end of tubing 100 may be removablycoupled to urine bag 9901. In various embodiments, graphical indicator642 may be located a proximal distance from the connection of secondterminal end 102 and urine bag 9901, such as from 0.125 to 7.000 inchesfrom this connection, i.e. graphical indicator 642 may be locatedrelatively close to this connection. In other embodiments, differentdimensions for the proximal distance may be employed. Second terminalend 102 may be defined by a region which encompasses this connection andgraphical indicator 642. Graphical indicator 642 may be located closerto this connection than to first terminal end 101.

In various embodiments, graphical indicator 642 may comprise tape, suchas an adhesive tape, which may be wrapped around tubing 100 in thevicinity of second terminal end 102. In such embodiments, the tape doesnot necessarily have to wrap the connection itself, as the intent ofsuch tape may not be to prevent disengagement of the connection, butrather to indicate that such an end may be appropriately and safelydisengaged and still maintain a closed-system.

In various embodiments, graphical indicator 642 may be a color wherebysuch a color choice may indicate to a viewer, such as a medicalpractitioner, that this end of tubing 100 may be opened and disengagedfrom urine bag 9901, as long as proper steps are taken to minimizeingress of contaminants, such as microbes, into tubing 100. For example,and without limiting the scope of the present invention, such a colormight be green. Such a color choice may also be explained in variousproduct literature, such as product inserts and media which may be foundonline instructing proper use of tubing 100.

Having discussed and disclosed the inventive tubing in its variousembodiments, this disclosure now turns to discussing the inventivesystems which may comprise the inventive tubing as discussed above.

A system for forming and maintaining a closed-system with respect totubing 100 connected to catheter 9915 may comprise: tubing 100, a secondconnector (e.g., 307 or 205), and catheter 9915. The entirety ofcomponentry as depicted in FIG. 4 may depict such a system.

Tubing 100 may comprise: first terminal end 101, second terminal end102, first tube 409, second tube 410, and a first connector withcheck-valve (e.g., 205 or 307 coupled with 308). First tube 409 maycomprise first terminal end 101 and third terminal end 411. Firstterminal end 101 may longitudinally oppose third terminal end 411.Second tube 410 may comprise second terminal end 102 and fourth terminalend 412. Second terminal end 102 may longitudinally opposes fourthterminal end 412. The first connector may comprise a check-valve. Such acheck-valve may either be connector integrated with check-valve 205 orconnector 307 that has been coupled to check-valve 308. The firstconnector with check-valve may be used to connect third terminal end 411to fourth terminal end 412, forming a joint between third terminal end411 and fourth terminal end 412. First terminal end 101 maylongitudinally oppose second terminal end 102.

In some embodiments, tubing 100 of the system may comprise couplingsleeve 206. Coupling sleeve 206 may circumscribe the joint. Couplingsleeve 206 may be configured to prevent third terminal end 411 frombecoming disengaged from fourth terminal end 412. As noted above,coupling sleeve 206 may grip the joint (exterior of the joint) by thebonding means. Coupling sleeve 206 may comprise tape 206 b. Tape 206 bmay be an adhesive tape. Tape 206 b may be a bright color, such as red.

Catheter 9915 may comprise exit port 9917. A second connector may beused to connect first terminal end 101 to exit port 9917 such thatsecond terminal end 102 remains available to removably couple to urinebag 9901.

The second connector may or may not comprise a check-valve. When thesecond connector has no check-valve, the second connector may beconnector 307. When the second connector comprises a check-valve, thesecond connector may be connector integrated with check-valve 205 or thesecond connector may be connector 307 coupled to check-valve 308.

In various embodiments the various check-valves of the system may or maynot comprise the antimicrobial coating. In various embodiments thesystem may comprise one or more biofilm abaters 613 located withintubing 100, and generally with at least one biofilm abater 613 locatedupstream of the first connector with check-valve. In variousembodiments, the system may also comprise one or more inside surfaceregion 622's, and generally with at least one inside surface region 622located upstream of the first connector with check-valve. In variousembodiments, the system may also comprise urine bag 9901.

When urine bag 9901 may be removed from second terminal end 102, thesystem may still be deemed closed from upstream of the first connectorwith check-valve that may be located within tubing 100; while open fromdownstream of the first connector with check-valve. In order to maintainthe system closed from near second terminal end 102, when urine bag 9901may be removed, additional componentry (e.g., a clamp or a cap) andvarious methods may be employed to close second terminal end 102.

Having discussed and disclosed various inventive tubing embodiments andinventive systems, this disclosure now turns to various methods forforming and maintaining a closed-system with respect to tubing 100connected to catheter 9915.

A method for forming and maintaining a closed-system with respect totubing 100 connected to catheter 9915 may comprise the steps:

Step 1: Cutting a segment of urinary tubing 100 for a purpose ofconnecting the segment of urinary tubing 100 to catheter 9915 and to aurine bag 9901.

Step 2: Forming a first connection between the segment of urinary tubing100 and catheter 9915 by connecting first terminal end 101 of thesegment of urinary tubing to exit port 9917 of catheter 9915 using afirst connector. (Note, the first connector here in methods context isnot the first connector discussed above in the systems discussion;rather the first connector here in the methods context is more akin tothe second connector of systems discussion.)

Step 3: Wrapping the first connection with a first piece of tape 206 bto prevent the first connection from becoming disengaged which minimizesingress of contaminants, such as microbes, into the closed-system. Thisstep may be optional, yet the step may be important.

Second terminal end 102 of the segment of urinary tubing 100 may beavailable for connection to urine bag 9901. Second terminal end 102 ofthe segment of urinary tubing 100 may be removably connected to urinebag 9901. Also with respect to Step 3, as discussed above, tape 206 bmay be colored, such as red, to indicate to a viewer to not disengagefirst terminal end 101 from exit port 9917 unless it may be time forcatheter removal or other steps are taken to maintain the system asclosed.

In various embodiments there may an additional step which precedes Step2, wherein before making the first connection, exit port 9917, firstterminal end 101, and the first connector are sterilized by treatingeach component with a sterilizing material. Such treating may beimmersing the component within the sterilizing material. Or treating maybe wiping the component down with the sterilizing material. Thesterilizing material may comprise a liquid, foam, or towel wetted withthe liquid or foam. The liquid or the foam may be various alcohols(e.g., isopropyl), bleach, peroxides, betadine, and the like.

The first connector may comprise a check-valve. The first connector mayeither comprise a check-valve such that the first connector and thecheck-valve are integral being a single article of manufacture, i.e.,first connector may be connector integrated with check-valve 205. Or,the first connector may comprise a non-integral check-valve which iscoupled to the first connector, i.e., first connector may be connector307 coupled to check-valve 308.

The method for forming and maintaining a closed-system with respect totubing 100 connected to catheter 9915 may comprise the followingadditional steps:

Step A: Cutting the segment of urinary tubing 100 into first tube 409and second tube 410. First tube 409 may comprise first terminal end 101and third terminal end 411. First terminal end 101 may longitudinallyoppose third terminal end 411. Second tube 410 may comprise secondterminal end 102 and fourth terminal end 412. Second terminal end 102may longitudinally oppose fourth terminal end 412.

Step B: Forming a second connection between first tube 409 and secondtube 410 by using a second connector to connect third terminal end 411to fourth terminal end 412. (Note, the second connector here in methodscontext is not the second connector discussed above in the systemsdiscussion; rather the second connector here in the methods context ismore akin to the first connector of systems discussion.)

In various embodiments, Step A and Step B may proceed Step 2. In variousembodiments, before making the second connection in Step B, thirdterminal end 411, fourth terminal end 412, and the second connector maybe sterilized by treating each of the components with the sterilizingmaterial.

In various embodiments, the second connection may comprise the step ofsecuring the second connection with coupling sleeve 206. Coupling sleeve206 may circumscribe the joint between third terminal end 411 and fourthterminal end 412. Coupling sleeve 206 may be configured to prevent thirdterminal end 411 from becoming disengaged from fourth terminal end 412which may minimize ingress of contaminants, such as microbes, into theclosed-system.

The step of securing coupling sleeve 206 to the joint may involvewrapping tape 206 b around the joint, i.e., coupling sleeve 206 maycomprise tape 206 b, which may be an adhesive tape. Tape 206 b may becolored, such as red, to indicate to a viewer that the second connectionshould not be opened unless intended to open the system.

Alternatively, the step of securing coupling sleeve 206 to the joint mayinvolve the step of bonding coupling sleeve 206 to outside diameter 104of tubing 100 in a region proximal to each side of the joint to preventthe second connection from becoming disengaged. Such bonding may beaccomplished by the bonding means, e.g., of ultrasonic welding, solventbonding, use of chemical adhesives, and the like.

The second connector may comprise a check-valve. The second connectormay either comprise a check-valve such that the second connector and thecheck-valve are integral being a single article of manufacture, i.e.,second connector may be connector integrated with check-valve 205. Or,the second connector may comprise a non-integral check-valve which maybe coupled to the second connector, i.e., the second connector may beconnector 307 coupled to check-valve 308.

The method for forming and maintaining a closed-system with respect totubing 100 connected to catheter 9915 may comprise the followingadditional steps:

Step 4: Attach graphical indicator 642 to outside diameter of tubing 104at the proximal distance from second terminal end 102. See FIG. 6H andthe above discussion of graphical indicator 642. In some embodiments,graphical indicator 642 may be green colored adhesive tape. In someembodiments, Step 4 may be optional.

Step 5: When urine bag 9901 may be changed by removing urine bag 9901and replacing urine bag 9901 with a new urine bag, the segment ofurinary tubing 100 may be clamped shut with a clamp prior to removal ofurine bag 9901. The clamp may remain in place until the new urine bagmay be attached to second terminal end 102 at which point the clamp maybe removed. It may be desirable to clamp shut tubing 100 as near aspossible to second terminal end 102 without interfering with themechanics of removing and attaching urine bag 9901. In some embodiments,Step 5 may be optional.

In various methods, the clamping step may be replaced with a cappingstep. When urine bag 9901 may be changed by removing urine bag 9901 andreplacing urine bag 9901 with a new urine bag, second terminal end 102may be capped shut with a cap, preferably a sterile cap, prior toremoval of urine bag 9901. The cap may remain in place until the newurine bag may be attached to second terminal end 102 at which point thecap may be removed.

FIG. 7A through and including FIG. 7K may at least depict an embodimentof a connector-with-integrated-check-valve 700 or may depict componentsof connector-with-integrated-check-valve 700. In some embodiments,connector-with-integrated-check-valve 700 may be a dual ended connectorwith an integral check-valve disposed between the opposing tubingconnection regions; wherein that integral check-valve may prevent urinereflux (backflow). The dual connector aspect may allow for connectingone end of connector-with-integrated-check-valve 700 to catheter-tubing9920 and the remaining other connector end to extension-tubing 9930. Insome embodiments, catheter-tubing 9920 may be the exit tubing portion ofcatheter 9915. In some embodiments, extension-tubing 9930 may then leadto urine bag 9901, such as, but not limited to, leg urine bag 9901 a orbed urine bag 9901 b.

FIG. 7A may depict a perspective and longitudinal cross-sectional viewof connector-with-integrated-check-valve 700 that may be attached tocatheter-tubing 9920 at one end and attached to extension-tubing 9930 atthe other end of connector-with-integrated-check-valve 700. FIG. 7B mayalso depict connector-with-integrated-check-valve 700, but shown in anexploded, perspective, and longitudinal cross-sectional view. FIG. 7Cmay also depict connector-with-integrated-check-valve 700, but shown inan exploded and a perspective view (not cross-sectional).

Discussing FIG. 7A, FIG. 7B, and FIG. 7C, in some embodiments,connector-with-integrated-check-valve 700 may comprise three parts thatmay be assembled together. In some embodiments these three parts may beconnector-for-catheter-tubing 710, connector-for-extension-tubing 730,and a gate 750.

Continuing discussing FIG. 7A, FIG. 7B, and FIG. 7C, in someembodiments, connector-for-catheter-tubing 710 may be removablyattachable to catheter-tubing 9920 at a first-barb-region 712 ofconnector-for-catheter-tubing 710. In some embodiments,connector-for-catheter-tubing 710 may be a first-elongate-member. Insome embodiments, connector-for-catheter-tubing 710 may comprise afirst-hollow-core 714 for passage of urine. In some embodiments,disposed opposite of first-barb-region 712 may be a mating-end 716 ofconnector-for-catheter-tubing 710.

Continuing discussing FIG. 7A, FIG. 7B, and FIG. 7C, in someembodiments, connector-for-catheter-tubing 710 may be rigid orsemi-rigid. In such embodiments, connector-for-catheter-tubing 710 maybe injection molded and/or 3D printed from one or more thermoformedplastics. In such embodiments, connector-for-catheter-tubing 710 may betransparent or substantially transparent, which may aid in facilitatingvisual inspections for defects, biofilms, and the like. In suchembodiments, connector-for-catheter-tubing 710 may be colored, such as,but not limited to, white.

Continuing discussing FIG. 7A, FIG. 7B, and FIG. 7C, in someembodiments, connector-for-catheter-tubing 710 may be an elongate member(e.g., the first-elongate-member) that may be radially symmetrical withrespect to a longitudinal central axis of connector-for-catheter-tubing710. Continuing discussing FIG. 7A, FIG. 7B, and FIG. 7C,first-barb-region 712 may be tiered. In some embodiments,first-barb-region 712 may be tiered hose-barbs.

Continuing discussing FIG. 7A, FIG. 7B, and FIG. 7C, in someembodiments, connector-for-catheter-tubing 710 may comprise acentral-flange 720. In some embodiments, central-flange 720 may be isexternally located and annular. In some embodiments, central-flange 720may be located between first-barb-region 712 and mating-end 716. In someembodiments, central-flange 720 may help to facilitate disassembly ofcatheter-tubing 9920 from first-barb-region 712 ofconnector-for-catheter-tubing 710; e.g., by the user grabbingcentral-flange 720 in one hand and grabbing catheter-tubing 9920 in theother hand and pulling apart.

Continuing discussing FIG. 7A, FIG. 7B, and FIG. 7C, in someembodiments, connector-for-extension-tubing 730 may be attachable toextension-tubing 9930 at a second-barb-region 732 ofconnector-for-extension-tubing 730. In some embodiments,connector-for-extension-tubing 730 may be a second-elongate-member. Insome embodiments, connector-for-extension-tubing 730 may comprise asecond-hollow-core 734 for passage of the urine. In some embodiments,disposed opposite of second-barb-region 732 may be acomplimentary-mating-end 736. In some embodiments, mating-end 716 (ofconnector-for-catheter-tubing 710) may be attached tocomplimentary-mating-end 736 (of connector-for-extension-tubing 730).

Continuing discussing FIG. 7A, FIG. 7B, and FIG. 7C, in someembodiments, connector-for-extension-tubing 730 may be rigid orsemi-rigid. In such embodiments, connector-for-extension-tubing 730 maybe injection molded and/or 3D printed from one or more thermoformedplastics. In such embodiments, connector-for-extension-tubing 730 may betransparent or substantially transparent, which may aid in facilitatingvisual inspections for defects, bio-films, and the like.

Continuing discussing FIG. 7A, FIG. 7B, and FIG. 7C, in someembodiments, connector-for-extension-tubing 730 may be an elongatemember (e.g., the second-elongate-member) that may be radiallysymmetrical with respect to a longitudinal central axis ofconnector-for-extension-tubing 730.

Continuing discussing FIG. 7A, FIG. 7B, and FIG. 7C, in someembodiments, second-barb-region 732 may be tiered. In some embodiments,second-barb-region 732 may be tiered hose-barbs.

Continuing discussing FIG. 7A, FIG. 7B, and FIG. 7C, in someembodiments, connector-for-extension-tubing 730 may comprise a flange738. In some embodiments, flange 738 may be externally located andannular. In some embodiments flange 738 may be located away fromsecond-barb-region 732.

Continuing discussing FIG. 7A, FIG. 7B, and FIG. 7C, in someembodiments, gate 750 may be comprise one or more of the followingproperties: may be a circular disc; may be disc shaped; may besubstantially disc shaped; may be a solid member; may be flexible; maybe elastomeric; may be constructed from silicone; may be constructedfrom rubber; may be radially symmetrical; and/or the like. In someembodiments, gate 750 may be a circular shaped disc, that may beelastomeric, and flexible.

Continuing discussing FIG. 7A, FIG. 7B, and FIG. 7C, in someembodiments, when the connector-for-catheter-tubing 710 may be attachedto the connector-for-extension-tubing 730 (e.g., via a union ofmating-end 716 to complimentary-mating-end 736), with the gate 750disposed between portions of connector-for-catheter-tubing 710 andportions of connector-for-extension-tubing 730; thenconnector-with-integrated-check-valve 700 may be formed from theconnector-for-catheter-tubing 710, the connector-for-extension-tubing730, and the gate 750.

Continuing discussing FIG. 7A, FIG. 7B, and FIG. 7C, in someembodiments, connector-with-integrated-check-valve 700 may permits urineflow is a desired-direction 770 from connector-for-catheter-tubing 710towards connector-for-extension-tubing 730. Whereas, in someembodiments, connector-with-integrated-check-valve 700 may close andprevent backflow (reflux) of the urine in a direction fromconnector-for-extension-tubing 730 towards connector-for-catheter-tubing710 when the urine exerts backflow pressure against gate 750, which maypush gate 750 against a seat 718 that may be located withinconnector-for-catheter-tubing 710. In some embodiments, seat 718 may bestructure of connector-for-catheter-tubing 710 located on or infirst-hollow-core 714. In some embodiments, seat 718 may be an internalannular shelf located in first-hollow-core 714. In some embodiments,seat 718 may stop movement of gate 750. In some embodiments, seat 718may form a seal with proximate portions of gate 750 whenconnector-with-integrated-check-valve 700 may be in the closedconfiguration.

FIG. 7D and FIG. 7E may depict connector-with-integrated-check-valve 700in an open configuration. FIG. 7D may depictconnector-with-integrated-check-valve 700, shown in a longitudinalcross-sectional view. FIG. 7E may be a close up view ofconnector-with-integrated-check-valve 700 shown in FIG. 7D. In the openconfiguration, gate 750 may not be touching seat 718.

Discussing FIG. 7E, FIG. 7B, and FIG. 7C, in some embodiments,connector-for-extension-tubing 730 may comprise catch-arms 740. In someembodiments, connector-for-extension-tubing 730 may comprise from two,three, four, five, or six catch-arms 740. In some embodiments,connector-for-extension-tubing 730 may comprise four catch-arms 740. Insome embodiments, catch-arms 740 may be arranged radially with respectto a center of connector-for-extension-tubing 730 (see e.g., FIG. 7J).In some embodiments, a given catch-arm 740 may be a structuralprotrusion into a portion of the second-hollow-core 734 that may allowurine flow through second-hollow-core 734 but wherein the catch-arms 740may be sized in relation to gate 750 to prevent the gate 750 frompassing through a region of second-hollow-core 734 that is closest tosecond-barb-region 732. In some embodiments, catch-arms 740 may stopmovement of gate 750 in desired-direction 770 from passing into orbeyond second-barb-region 732. In some embodiments, catch-arms 740 mayact as guides for some movement of gate 750.

Discussing FIG. 7E, FIG. 7B, and FIG. 7C, in some embodiments, eachcatch-arm 740 may comprise a support-surface 742. See also, FIG. 7J andFIG. 7K. In some embodiments, support-surface 742 may be located closerto complimentary-mating-end 736 than to second-barb-region 732. In someembodiments, support-surface 742 may be disposed opposite from seat 718and facing the seat 718. In some embodiments, disposed between seat 718and support-surface 742 may be a pocket 752 that may house gate 750. Seee.g., FIG. 7E for pocket 752. In some embodiments, support-surface 742may contact portions of gate 750 when the urine is flowing indesired-direction 770. In some embodiments, when the urine is flowingdesired-direction 770 this direction of flow may create pressure upongate 750, wherein this may push gate 750 against support-surfaces 742,which may be open configuration shown in FIG. 7E and in FIG. 7D. Urinemay flow around the arm structures of catch-arms 740 throughfirst-hollow-core 714.

Discussing FIG. 7E, FIG. 7B, and FIG. 7C, in some embodiments, eachcatch-arm 740 may comprise a post 746. In some embodiments, post 746 mayprotrude away from support-surface 742. See also, FIG. 7J and FIG. 7K.

Discussing FIG. 7E, FIG. 7B, and FIG. 7C, in some embodiments, gate 750may float within pocket 752 of connector-with-integrated-check-valve700. See FIG. 7E for pocket 752. In some embodiments, pocket 752 may belongitudinally bounded by seat 718 at one end of pocket 752 and bysupport-surfaces 742 at a remaining end of pocket 752. In someembodiments, support-surfaces 742 may be disposed opposite of seat 718and may face seat 718. In some embodiments, support-surfaces 742 may besupportive surfaces of catch-arms 740. In some embodiments, catch-arms740 may permit the urine flow through second-hollow-core 734 but may notpermit passage of gate 750 into portions of second-hollow-core 734. Insome embodiments, gate 750 may translate in pocket 752, between the openconfiguration and the closed configuration.

FIG. 7F and FIG. 7G may depict connector-with-integrated-check-valve 700in the closed configuration. FIG. 7F may depictconnector-with-integrated-check-valve 700, shown in a longitudinalcross-sectional view. FIG. 7G may be a close up view ofconnector-with-integrated-check-valve 700 shown in FIG. 7F. In theclosed configuration, gate 750 may be touching seat 718. In the closedconfigurations, portions of gate 750 closest to seat 718 may bephysically touching portions of seat 718.

FIG. 7H may depict connector-with-integrated-check-valve 700, shown in aperspective view, an assembled perspective view; whereinconnector-with-integrated-check-valve 700 may be attached tocatheter-tubing 9920 and attached to extension-tubing 9930.

FIG. 7I may show an outlet perspective view ofconnector-for-catheter-tubing 710, which may be a component ofconnector-with-integrated-check-valve 700. In some embodiments, FIG. 7Imay depict a system for minimizing microbial migration tocatheter-tubing. In some embodiments, this system may compriseextension-tubing 9930 of a predetermined length andconnector-with-integrated-check-valve 700 attached to that predeterminedlength of extension-tubing 9930.

FIG. 7J may show an inlet view of connector-for-extension-tubing 730,which may be a component of connector-with-integrated-check-valve 700.FIG. 7K may depict an inlet perspective view of theconnector-for-extension-tubing 730. In some embodiments, a distancebetween opposing posts 746 may be receiving-distance 744. See FIG. 7Jfor receiving-distance 744. In some embodiments, gate 750 may comprise agate-outside-diameter 754 which may be an outside diameter of gate 750.See FIG. 7C for gate-outside-diameter 754. In some embodiments,gate-outside-diameter 754 may be less than receiving-distance 744; andin this relationship, portions of catch-arms 740 (e.g., spaced posts746) may help to guide movement of gate 750 within pocket 752.

In some embodiments, mating-end 716 (of connector-for-catheter-tubing710) may be a protruding annular ring that may protrude in a directionaway from the first-barb-region 712. See e.g., FIG. 7I, FIG. 7B, FIG.7E, and FIG. 7G. In some embodiments, complimentary-mating-end 736 maybe a ring shaped receiving channel sized to receive the protrudingannular ring of mating-end 716. For complimentary-mating-end 736 seeFIG. 7J, FIG. 7K, FIG. 7B, FIG. 7E, and FIG. 7G. In some embodiments,this ring shaped receiving channel of complimentary-mating-end 736 maybe located in flange 738. See e.g., FIG. 7B. In some embodiments,attachment between mating-end 716 and complimentary-mating-end 736 maybe by one or more of: ultrasonic welding, heat welding, solvent bonding,chemical adhesive, snap fit, friction fit, press fit, and/or the like.

FIG. 8 may depict a perspective and longitudinal cross-sectional view ofan embodiment of a connector-with-integrated-check-valve 800.Functionally, connector-with-integrated-check-valve 800 may differ fromconnector-with-integrated-check-valve 700, in that the check-valveaspect of connector-with-integrated-check-valve 800 may be typicallyclosed unless normal urine flow in desired-direction 770 opens thecheck-valve. Whereas, the check-valve aspect ofconnector-with-integrated-check-valve 700 may be normally open unlessthere is urine backflow (reflux) to close the integral check-valve. Insome embodiments, such function of connector-with-integrated-check-valve800 may be achieved by use of a spring, closing-spring 845, in thepocket, pocket 852. This closing-spring 845 may always be pressingagainst gate 750.

Discussing FIG. 8, in some embodiments,connector-with-integrated-check-valve 800 may comprise four parts, thatof: connector-for-catheter-tubing 710, gate 750,connector-for-extension-tubing 830, and closing-spring 852. Structurallyand functionally, gate 750 may be as discussed above for gate 750 inconnector-with-integrated-check-valve 700. Structurally andfunctionally, connector-for-catheter-tubing 710 may be as discussedabove for connector-for-catheter-tubing 710 inconnector-with-integrated-check-valve 700; with the exception that nowconnector-for-catheter-tubing 710 is attached toconnector-for-extension-tubing 830 and notconnector-for-extension-tubing 730.

Continuing discussing FIG. 8, in some embodiments,connector-for-extension-tubing 830 may be attachable to extension-tubing9930 at a second-barb-region 832 of connector-for-extension-tubing 830.In some embodiments, connector-for-extension-tubing 830 may be asecond-elongate-member. In some embodiments,connector-for-extension-tubing 830 may comprise a second-hollow-core 834for passage of the urine. In some embodiments, disposed opposite ofsecond-barb-region 832 may be a complimentary-mating-end 836. In someembodiments, mating-end 716 (of connector-for-catheter-tubing 710) maybe attached to complimentary-mating-end 836 (ofconnector-for-extension-tubing 830).

Continuing discussing FIG. 8, in some embodiments,connector-for-extension-tubing 830 may be rigid or semi-rigid. In suchembodiments, connector-for-extension-tubing 830 may be injection moldedand/or 3D printed from one or more thermoformed plastics. In suchembodiments, connector-for-extension-tubing 830 may be transparent orsubstantially transparent, which may aid in facilitating visualinspections for defects, biofilms, and the like.

Continuing discussing FIG. 8, in some embodiments,connector-for-extension-tubing 830 may be an elongate member (e.g., thesecond-elongate-member) that may be radially symmetrical with respect toa longitudinal central axis of connector-for-extension-tubing 830.

Continuing discussing FIG. 8, in some embodiments, second-barb-region832 may be tiered. In some embodiments, second-barb-region 832 may betiered hose-barbs.

Continuing discussing FIG. 8, in some embodiments,connector-for-extension-tubing 830 may comprise a flange 838. In someembodiments, flange 838 may be externally located and annular. In someembodiments flange 838 may be located away from second-barb-region 832.

Continuing discussing FIG. 8, in some embodiments, about mid-way alongsecond-hollow-core 834, inside of connector-for-extension-tubing 830,may be spring-stops 840; wherein “about” in this context may be plus orminus 25% of the length of connector-for-extension-tubing 830. In someembodiments, spring-stops 840 may be protrusions into second-hollow-core834, that do not prevent urine flow. In some embodiments, disposedbetween spring-stops 840 and seat 718 (of connector-for-catheter-tubing710), may be pocket 852. In some embodiments, closing-spring 845 andgate 750 may be located within pocket 852. In some embodiments,closing-spring 845 may be touching portions of spring-stops 840 andtouching portions of gate 750. In some embodiments, gate 750 may beremovably touching seat 718 and touching an end of closing-spring 845.In some embodiments, when there is normal urine flow indesired-direction 770, such normal urine pressure may press against gate750, which in turn may then press against closing-springdesired-direction 770, which opens this integral check-valve and allowsnormal urine flow into extension-tubing 9930. When such normal urineflow ceases, then closing-spring 845 may then close gate 750 againstseat 718, to close this integral check-valve.

FIG. 9A may depict a perspective and longitudinal cross-sectional viewof an embodiment of a connector-with-integrated-check-valve 900. FIG. 9Bmay depict connector-with-integrated-check-valve 900, but shown in anexploded and a perspective view. Functionally,connector-with-integrated-check-valve 900 may differ fromconnector-with-integrated-check-valve 700, in that the check-valveaspect of connector-with-integrated-check-valve 900 may be typicallyclosed unless normal urine flow in desired-direction 770 opens thecheck-valve. Whereas, the check-valve aspect ofconnector-with-integrated-check-valve 700 may be normally open unlessthere is urine backflow (reflux) to close the integral check-valve. Insome embodiments, such function of connector-with-integrated-check-valve900 may be achieved by use of a hinge gate, i.e., a flapper gate, as ingate 950, in the pocket, pocket 940.

Discussing FIG. 9A and FIG. 9B, in some embodiments,connector-with-integrated-check-valve 800 may comprise three parts, thatof: connector-for-catheter-tubing 710, gate 950, andconnector-for-extension-tubing 930. Structurally and functionally, gate950 may be as discussed above for gate 750 inconnector-with-integrated-check-valve 700; except gate 950 may compriseadditional structure, that of hinge 956. In some embodiments, gate 950may be a substantially circular shaped disc, with the extension of hinge956, that may be elastomeric, and flexible. Structurally andfunctionally, connector-for-catheter-tubing 710 may be as discussedabove for connector-for-catheter-tubing 710 inconnector-with-integrated-check-valve 700; with the exception that nowconnector-for-catheter-tubing 710 is attached toconnector-for-extension-tubing 930 and notconnector-for-extension-tubing 730.

Discussing FIG. 9A and FIG. 9B, in some embodiments,connector-for-extension-tubing 930 may be attachable to extension-tubing9930 at a second-barb-region 932 of connector-for-extension-tubing 930.In some embodiments, connector-for-extension-tubing 930 may be asecond-elongate-member. In some embodiments,connector-for-extension-tubing 930 may comprise a second-hollow-core 934for passage of the urine. In some embodiments, disposed opposite ofsecond-barb-region 932 may be a complimentary-mating-end 936. In someembodiments, mating-end 716 (of connector-for-catheter-tubing 710) maybe attached to complimentary-mating-end 936 (ofconnector-for-extension-tubing 930).

Discussing FIG. 9A and FIG. 9B, in some embodiments,connector-for-extension-tubing 930 may be rigid or semi-rigid. In suchembodiments, connector-for-extension-tubing 930 may be injection moldedand/or 3D printed from one or more thermoformed plastics. In suchembodiments, connector-for-extension-tubing 930 may be transparent orsubstantially transparent, which may aid in facilitating visualinspections for defects, biofilms, and the like.

Discussing FIG. 9A and FIG. 9B, in some embodiments,connector-for-extension-tubing 930 may be an elongate member (e.g., thesecond-elongate-member) that may be radially symmetrical with respect toa longitudinal central axis of connector-for-extension-tubing 930.

Discussing FIG. 9A and FIG. 9B, in some embodiments, in someembodiments, second-barb-region 932 may be tiered. In some embodiments,second-barb-region 932 may be tiered hose-barbs.

Discussing FIG. 9A and FIG. 9B, in some embodiments,connector-for-extension-tubing 930 may comprise a flange 938. In someembodiments, flange 938 may be externally located and annular. In someembodiments flange 938 may be located away from second-barb-region 932.

Discussing FIG. 9A and FIG. 9B, in some embodiments, proximate tocomplimentary-mating-end 936, inside of connector-for-extension-tubing930, may be stop 942; wherein “proximate” in this context may be plus orminus 25% of the length of connector-for-extension-tubing 930. In someembodiments, stop 942 may be a narrowing of an inside diameter ofsecond-hollow-core 934, that does not prevent urine flow, but that isnarrower than gate-outside-diameter 954 of gate 950, which may preventpassage of gate 950 into portions of second-hollow-core 934. In someembodiments, disposed between stop 942 and seat 718 (ofconnector-for-catheter-tubing 710), may be pocket 940. In someembodiments, gate 950 may be located within pocket 852. In someembodiments, gate 950 may be removably touching seat 718. In someembodiments, pocket 940 may be a hollow cylinder. In some embodiments ata distal end of pocket 940 may be a notch, a hinge-receiver 944 forreceiving hinge 956 of gate 950. In some embodiments, around a perimeterof gate 950 may be an extending tab, that of hinge 956. In someembodiments, this tab of hinge 956 may fit into the notch ofhinge-receiver 944. In this way, gate 950 may removably rest againstseat 718 when where there is no urine flow; and when there is urine flowin desired-direction 770, then such urine pressure against gate 950 maycause portions of gate 950 to bend towards stop 942 and to stop at stop942, allowing urine to flow to extension-tubing 9930 through portions ofsecond-hollow-core 934.

In some embodiments, attachment between mating-end 716 andcomplimentary-mating-end (e.g., 736, 836, or 936) may be by one or moreof: ultrasonic welding, heat welding, solvent bonding, chemicaladhesive, snap fit, friction fit, press fit, and/or the like. In someembodiments, such attachment may be intended to be permanent. In someembodiments, such attachment may be intended to be removable.

In some embodiments, at least some of internal wettable surfaces ofconnector-with-integrated-check-valve 700 or ofconnector-with-integrated-check-valve 800 or ofconnector-with-integrated-check-valve 900 may be coated with anantimicrobial coating. In some embodiments, at least some of internalwettable surfaces of connector-with-integrated-check-valve 700 or ofconnector-with-integrated-check-valve 800 or ofconnector-with-integrated-check-valve 900 may be treated with anantimicrobial product. Such antimicrobial coatings and/or treatments mayhelp to prevent or minimize microbial colonization of the internalwettable surfaces. Such antimicrobial coatings and/or treatments mayhelp to prevent or minimize biofilm adhesion to the internal wettablesurfaces.

In some embodiments, any check-valve shown in FIG. 1A through FIG. 6Hmay be replaced with connector-with-integrated-check-valve (700, 800,and/or 900).

Note, in some embodiments, if a clamp is positioned aroundextension-tubing 9930, and if said clamp is closed preventing any airinto extension-tubing 9930 above the clamp, and prior to disengagingextension-tubing 9930 from the urine collection device urine bag 9901use of such a clamp would maintain a closed-system above the clamp whichwould also include a closed-system with respect to catheter 9915.

A tubing for minimizing undesirable microbial migration, as well as asystem and method for forming and maintaining a closed-system of urinarytubing have been described. A connector-with-integrated-check-valve hasalso been described. The foregoing description of the variousembodiments of the invention has been presented for the purposes ofillustration and disclosure. It is not intended to be exhaustive or tolimit the invention to the precise form disclosed. Many modificationsand variations are possible in light of the above teaching withoutdeparting from the spirit of the invention.

While the invention has been described in connection with what ispresently considered to be the most practical and preferred embodiments,it is to be understood that the invention is not to be limited to thedisclosed embodiments, but on the contrary, is intended to cover variousmodifications and equivalent arrangements included within the spirit andscope of the appended claims.

What is claimed is:
 1. A connector-with-integrated-check-valvecomprising: a connector-for-catheter-tubing that is removably attachableto catheter-tubing at a first-barb-region of theconnector-for-catheter-tubing; wherein the connector-for-catheter-tubingis a first-elongate-member; wherein the connector-for-catheter-tubingcomprises a first-hollow-core for passage of urine; wherein disposedopposite of the first-barb-region is a mating-end; aconnector-for-extension-tubing that is attachable to extension-tubing ata second-barb-region of the connector-for-extension-tubing; wherein theconnector-for-extension-tubing is a second-elongate-member; wherein theconnector-for-extension-tubing comprises a second-hollow-core forpassage of the urine; wherein disposed opposite of thesecond-barb-region is a complimentary-mating-end; wherein the mating-endis attached to the complimentary-mating-end; and a gate; wherein whenthe connector-for-catheter-tubing is attached to theconnector-for-extension-tubing, with the gate disposed between portionsof the connector-for-catheter-tubing and portions of theconnector-for-extension-tubing; theconnector-with-integrated-check-valve is formed from theconnector-for-catheter-tubing, the connector-for-extension-tubing, andthe gate; wherein the connector-with-integrated-check-valve permitsurine flow is a desired-direction from the connector-for-catheter-tubingtowards the connector-for-extension-tubing; wherein theconnector-with-integrated-check-valve closes and prevents backflow ofthe urine in a direction from the connector-for-extension-tubing towardsthe connector-for-catheter-tubing when urine exerts backflow pressureagainst the gate, which pushes the gate against a seat that is structurelocated within the connector-for-catheter-tubing.
 2. Theconnector-with-integrated-check-valve according to claim 1, wherein theconnector-for-catheter-tubing is rigid.
 3. Theconnector-with-integrated-check-valve according to claim 1, wherein theconnector-for-catheter-tubing comprises a central-flange that isexternally located and annular; wherein this central-flange is locatedbetween the first-barb-region and the mating-end.
 4. Theconnector-with-integrated-check-valve according to claim 1, wherein theconnector-for-extension-tubing is rigid.
 5. Theconnector-with-integrated-check-valve according to claim 1, wherein theconnector-for-extension-tubing comprises a flange that is externallylocated and annular; wherein this flange is located away from thesecond-barb-region.
 6. The connector-with-integrated-check-valveaccording to claim 1, wherein the connector-for-extension-tubingcomprises catch-arms; wherein the catch-arms are structural protrusionsinto portions of the second-hollow-core that allow urine flow throughthe second-hollow-core but wherein the catch-arms that are sized inrelation to the gate to prevent the gate from passing through a regionof the second-hollow-core that is closest to the second-barb-region. 7.The connector-with-integrated-check-valve according to claim 6, whereineach catch-arm comprises a support-surface; wherein the support-surfaceis located closer to the complimentary-mating-end than to thesecond-barb-region; wherein the support-surface is disposed oppositefrom the seat and facing the seat; wherein disposed between the seat andthe support-surface is a pocket that houses the gate; wherein thesupport-surface contacts portions of the gate when urine is flowing inthe desired-direction.
 8. The connector-with-integrated-check-valveaccording to claim 7, wherein each catch-arm comprises a post; whereinthe post protrudes away from the support-surface.
 9. Theconnector-with-integrated-check-valve according to claim 1, wherein thegate comprises one or more of the following properties: is a circulardisc; is a solid member; is flexible; is elastomeric; is constructedfrom silicone; is constructed from rubber; or is radially symmetrical.10. The connector-with-integrated-check-valve according to claim 1,wherein the gate floats within a pocket of theconnector-with-integrated-check-valve; wherein the pocket islongitudinally bounded by the seat at one end of the pocket and by asupport-surface at a remaining end of the pocket; wherein thesupport-surface is disposed opposite of the seat and faces the seat;wherein the support-surface is a supportive surface of a catch-arm andthe catch-arm is a structural protrusion into a portion of thesecond-hollow-core; wherein the catch-arm permits urine flow through thesecond-hollow-core but does not permit passage of the gate into theportion of the second-hollow-core; wherein the gate translates in thepocket.
 11. The connector-with-integrated-check-valve according to claim1, wherein the gate has a gate-outside-diameter that is less than areceiving-distance between posts of opposing catch-arms.
 12. Theconnector-with-integrated-check-valve according to claim 1, wherein themating-end is a protruding annular ring that protrudes in a directionaway from the first-barb-region; wherein the complimentary-mating-end isa ring shaped receiving channel sized to receive the protruding annularring.
 13. The connector-with-integrated-check-valve according to claim1, wherein attachment between the mating-end and thecomplimentary-mating-end is by one or more of: ultrasonic welding, heatwelding, solvent bonding, chemical adhesive, snap fit, friction fit, orpress fit.
 14. The connector-with-integrated-check-valve according toclaim 1, wherein the connector-with-integrated-check-valve furthercomprises a predetermined length of the extension-tubing that has oneend of that extension-tubing attached to the second-barb-region.
 15. Theconnector-with-integrated-check-valve according to claim 1, wherein atleast some of internal wettable surfaces of theconnector-with-integrated-check-valve are coated with an antimicrobialcoating.
 16. The connector-with-integrated-check-valve according toclaim 1, wherein at least some of internal wettable surfaces of theconnector-with-integrated-check-valve are treated with an antimicrobialproduct.
 17. A connector-with-integrated-check-valve formed from threeparts: a connector-for-catheter-tubing that is elongate, hollow, rigid,and with an internal annular shelf; a gate that is elastomeric andsubstantially disc shaped; and a connector-for-extension-tubing; that iselongate, hollow, rigid, and with support-surfaces; wherein one end ofthe connector-for-catheter-tubing is attached to one end of theconnector-for-extension-tubing a pocket is formed where the internalannular shelf is disposed opposite and facing the support-surfaces;wherein the gate is disposed within this pocket; wherein the internalannular shelf is a sealing seat such that when proximate portions of thegate contact this internal annular shelf due to urine backflow, theconnector-with-integrated-check-valve is closed to urine flow; andwherein a remaining end of the connector-for-catheter-tubing isattachable to catheter-tubing; and wherein a remaining end of theconnector-for-extension-tubing is attachable to the extension-tubing,such that there is a continuous urine flow path from thecatheter-tubing, to the connector-with-integrated-check-valve when open,and to the extension-tubing.
 18. A system for minimizing microbialmigration to catheter-tubing comprising: extension-tubing of apredetermined length; a connector-with-integrated-check-valvecomprising: a connector-for-catheter-tubing that is removably attachableto catheter-tubing at a first-barb-region of theconnector-for-catheter-tubing; wherein the connector-for-catheter-tubingis a first-elongate-member; wherein the connector-for-catheter-tubingcomprises a first-hollow-core for passage of urine; wherein disposedopposite of the first-barb-region is a mating-end; aconnector-for-extension-tubing that is attached to the extension-tubingat a second-barb-region of the connector-for-extension-tubing; whereinthe connector-for-extension-tubing is a second-elongate-member; whereinthe connector-for-extension-tubing comprises a second-hollow-core forpassage of the urine; wherein disposed opposite of thesecond-barb-region is a complimentary-mating-end; wherein the mating-endis attached to the complimentary-mating-end; and a gate; wherein whenthe connector-for-catheter-tubing is attached to theconnector-for-extension-tubing, with the gate disposed between portionsof the connector-for-catheter-tubing and portions of theconnector-for-extension-tubing; theconnector-with-integrated-check-valve is formed from theconnector-for-catheter-tubing, the connector-for-extension-tubing, andthe gate; wherein the connector-with-integrated-check-valve permitsurine flow is a desired-direction from the connector-for-catheter-tubingtowards the connector-for-extension-tubing; wherein theconnector-with-integrated-check-valve closes and prevents backflow ofthe urine in a direction from the connector-for-extension-tubing towardsthe connector-for-catheter-tubing when urine exerts backflow pressureagainst the gate, which pushes the gate against a seat that is structurelocated within the connector-for-catheter-tubing.